Enhancing self-care adherence in patients with heart failure

b’Subject: Nursing’
b’Topic: Enhancing self-care adherence in patients with heart failure: a study protocol for developing a theory-based behaviour change intervention using the COM-B behaviour model (ACHIEVE study)’
b’please follow this sequence:\n1.area of interest\n2.problem significance(figure and facts, statical data\n3.background\n4.Need of study\n5.Study purpose\n6.objectives\n7.litrature review\n8.methodology\n9. intervention\n\nkindnyzly use my sending article’

Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 1
Open access
Enhancing self-care adherence in
patients with heart failure: a study
protocol for developing a theory-based
behaviour change intervention using the
COM-B behaviour model (ACHIEVE
study)
Oliver Rudolf Herber,1 Louise Atkins,2 Stefan Störk,3 Stefan Wilm1
To cite: Herber OR, Atkins L,
Störk S, et al. Enhancing
self-care adherence in
patients with heart failure: a
study protocol for developing
a theory-based behaviour
change intervention using
the COM-B behaviour model
(ACHIEVE study). BMJ Open
2018;8:e025907. doi:10.1136/
bmjopen-2018-025907
► Prepublication history for
this paper is available online.
To view these files, please visit
the journal online (http://dx.doi.
org/10.1136/bmjopen-2018-
025907).
Received 7 August 2018
Revised 13 August 2018
Accepted 14 August 2018
1
Institute of General Practice
(ifam), Medical Faculty of
the Heinrich Heine University
Düsseldorf, Düsseldorf, Germany
2
UCL Centre for Behaviour
Change, University College
London, London, UK
3
Division of Cardiology at the
Outpatient Clinic of Medical
Department, Comprehensive
Heart Failure Center (CHFC),
University Hospital Würzburg,
Würzburg, Germany
Correspondence to
Dr Oliver Rudolf Herber;
Oliver.Herber@med.uniduesseldorf.de
Protocol
© Author(s) (or their
employer(s)) 2018. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
AbstrACt
Introduction Although international guidelines
recommend self-care as an integral part of routine heart
failure management, and despite evidence supporting
the positive outcomes related to self-care, patients are
frequently unable to adhere. Self-care can be modified
through behaviour change interventions (BCIs). However,
previous self-care interventions have shown limited
success in improving adherence to self-care, because
they were neither theory-based nor well defined,
which precludes the identification of underlying causal
mechanisms as well as reproducibility of the intervention.
Thus, our aim is to develop an intervention manual
that contains theory-based BCIs that are well-defined
using eight descriptors proposed to describe BCIs in a
standardised way.
Methods and analysis BCIs will be based on statements
of findings derived through qualitative meta-summary
techniques and a quantitative meta-analysis. These
reviews will be used to extract factors (target behaviours)
associated with self-care adherence/non-adherence.
Extracted target behaviours will be mapped onto the
‘Capability, Opportunity, Motivation and Behaviour’
(COM-B) model to capture the underlying mechanisms
involved. To develop approaches for change, the
‘Taxonomy of Behaviour Change Techniques’ will be used
to allow effective mapping of the target behaviours onto
established behaviour change techniques. Suggested
BCIs will then be translated into locally relevant
interventions using the Normalisation Process Theory to
overcome the difficulties of implementing theoretically
derived interventions into practice. Finally, a consensus
development method will be employed to fine-tune the
content and acceptability of the intervention manual
to increase the likelihood of successfully piloting and
implementing future BCIs into the German healthcare
system.
Ethics and dissemination This study has been
reviewed and approved by the Ethics Committee of
the Medical Faculty of the Heinrich Heine University
Düsseldorf, Germany (Ref #: 2018-30). The results will
be disseminated via peer-reviewed journal publications,
conference presentations and stakeholder engagement
activities.
trial registration number DRKS00014855; Pre-results.
IntroduCtIon
Heart failure (HF) is a major clinical and public
health problem worldwide associated with
significant healthcare expenditure, morbidity
and mortality.1 In Germany, the prevalence
of HF is estimated at 3%–4%among adults
and increases steeply with age.1Heart failure
is the most common cause of hospital admissions of patients and ranks third as cause of
death.1 Treatment costs are strongly driven
by expenditure for repeated hospitalisations
and increase with disease progression.2 Thus,
HF represents a growing public health and
health economic issue as the population ages.
On an individual level, patients with HF experience physical and psychological distress
such as fatigue, dyspnoea, pain, depression
or problems regarding concentration, all of
strengths and limitations of this study
► Behaviour change intervention (BCI) is based on
sound theoretical framework.
► Extensive consultation with potential key stakeholders, that is, end users and healthcare providers, will
inform intervention development.
► Final intervention manual will contain specific information regarding eight descriptors suggested
for the standardised description of BCIs to allow for
replication.
► Full randomised controlled trial (RCT) design not
possible within the study budget and time frame,
but study will collect important data to inform a fullscale RCT in the future.
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2 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
which are having a major negative impact on the person’s
quality of life.3
After being diagnosed with HF, the prognosis depends
on two major components: one is physician-based and
encompasses all aspects of appropriate treatment, monitoring of effects and communicating relevant information; the other is patient-based and refers to the
concept of self-care including the motivation to adhere
to diagnostic and therapeutic recommendations. HF
care should be exerted in a multidisciplinary team and
involves a patient-centred approach seeking to systematically develop emotional, physical, intellectual and
social resources of the patient.4 Ultimately, such strategy
is thought to empower patients in order to improve and
sustain efficacious self-care behaviour. The term self-care
refers to
the individual’s ability to manage the symptoms, treatment, physical and psychosocial consequences and
life style changes inherent in living with a chronic
condition. Efficacious self-care encompasses the ability to monitor one’s condition and to effect the cognitive, behavioural and emotional responses necessary
to maintain a satisfactory quality of life.5 (p. 178)
Since 2008, the European Guidelines for Diagnosis and
Treatment of HF strongly emphasise self-care (Grade IA
recommendation) as part of routine HF management
and patient empowerment.4 6
Generally, self-care mandates a sustained effort in order
to impact on any chronic disease. In particular, successful
HF therapy requires a substantial amount of self-care and
adherence to multiple aspects of the treatment regimen.7
For example, HF self-care encompasses a complex set of
behaviours including daily weighing, low-sodium diet,
fluid restriction, regular physical exercise, medication
taking, symptom monitoring involving exercising and
developing an awareness of exacerbating symptoms such
as shortness of breath, lower extremity oedema, fatigue or
activity intolerance.8 Hence, such adherence to HF selfcare is considered key in order to achieve a positive effect
on disease progression. Adherence is defined as the extent
to which a patient’s behaviour coincides with the recommendations made by healthcare providers.9 The concept
of adherence focuses on specific patient behaviours
emphasising the need for agreement between patient
and healthcare provider. Sound evidence from systematic reviews has shown that adherence to self-care significantly reduces HF-related hospitalisations,10 morbidity
and mortality,11 decreases hospital readmissions12 and
improves HF-related quality of life.13 Conversely, failure
to adhere to recommended self-care is associated with HF
exacerbation,14 frequent hospital readmissions and low
survival.15
Patients with HF are faced with the difficulty of
adopting complex recommendations including adherence to multiple aspects of the treatment regimen and
lifestyle adjustments in order to prevent disease progression. Self-management interventions aiming at improving
self-care generally seek to empower individuals by
endowing them with the skills necessary to actively participate in the management of their chronic condition.5
Several systematic reviews investigating the efficacy and
effectiveness of self-management interventions involving
home and/or clinic visits, education sessions (eg, ‘giving
information’), telemonitoring approaches and follow-up
telephone calls for patients with HF have been published
to date showing inconsistent results. Earlier conducted
systematic reviews had suggested a relevant benefit in relation to hard clinical endpoints including all-cause hospitalisation and HF-related hospitalisations.12 16 Despite
favourable pooled effects, some more recently conducted
large randomised controlled trials (RCTs) including
multisite studies showed inconsistent results.17–20 Thus,
the effectiveness of self-management interventions in
terms of all-cause hospitalisation, HF-related hospitalisations and death remains inconclusive until today. Part of
this heterogeneity may be attributable to the absence of
self-management interventions applying behaviour strategies and/or cognitive behavioural strategies (rather than
simply educational interventions), insufficient use of
theoretical models underpinning the intervention or lack
of detailed description of the active ingredient(s) driving
the intervention.
In more detail, evidence of grade A (high quality)
exists that interventions using established, well-defined
behaviour change techniques (ie, the ‘active ingredient’
of an intervention) are most effective.21 Yet, a review of
self-management interventions promoting self-care of
patients with HF came to the conclusion that only very
few studies used explicit theory-based interventions, while
the majority still lacked specificity of the mechanisms
employed to improve self-care.22 Such critique was also
articulated by Michie and colleagues,23 who stated that
interventions are commonly designed without applying
an evidence-based underlying model. Instead, interventions are frequently based on implicit common sense
models.24 Similarly, a most recent critical reflection on
methodological challenges encountered in meta-analyses
on self-care interventions advised intervention designers
to pay particular attention to the causal mechanisms
underlying the intervention when designing studies.25
Hence, absent effects of previous self-management interventions seeking to improve self-care may very well be
attributable to the lack of theoretical underpinning or
the use of ill-chosen strategies.26 27
Another criticism relates to the lack of detailed description of the active ingredient(s) driving a successful
intervention. Detailed descriptions are of paramount
importance for replication, allowing scientists to accumulate evidence about intervention effects and causal
mechanisms.28 For the results to be judged, reproducible, sufficiently detailed information must be provided
to allow the potential for reproducing the same or similar
results.29 Yet, specific features rendering interventions
successful are often ill-defined in research publications,
which limit reproducibility.18 Hence, a systematic method
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 3
Open access
that incorporates a thorough understanding of the nature
of the behaviour to be changed (ie, the target behaviour),
an appropriate system for characterising interventions
and their components as well as descriptors suggested for
the standardisation of reporting behaviour change interventions (BCIs) are mandatory. In this way, a ‘science of
change’ can be established in which effective interventions can be understood and replicated.30
In summary, it can be stated that inconclusive results of
existing self-management interventions for patients with
HF may very well be attributable to the absence of interventions applying behaviour strategies and/or cognitive
behavioural strategies, insufficient use of theoretical
models underpinning the intervention or lack of detailed
description of the active ingredient(s) driving the intervention, thus emphasising the need to design an intervention that allows for these likely sources of heterogeneity.
Therefore, the aim of this study is to develop well-defined
theory-based BCIs based on an underlying behaviour
model that allows for identifying effective behaviour
change techniques.
MEthods And AnAlysIs
Patient and public involvement
Our research question emerged from the findings of
published literature on self-management interventions as
described above. Patients and the public are involved in
this early stage of designing BCIs through their involvement as members of the participatory planning group.
To facilitate successful completion of each stage of the
proposed work programme as described below, a participatory planning group will be established right at the
beginning of the study. Intervention development and
implementation should be based on meaningful participation of key stakeholders.31 Thus, for the life of this
project, a participatory planning group will be deployed
to assist in the development of an intervention manual
containing well-defined theory-based BCIs. The planning group will be composed of key stakeholders who
have a particular interest in designing BCIs including
intervention developers, intervention implementers and
intervention end users (ie, patients with HF). For identifying key stakeholders, we will be using the guiding questions proposed by Preskill and Jones.32 They consider
the following five domains to be relevant for the selection process: (1) expertise, (2) diverse perspectives,
(3) responsibility and authority, (4) influence and (5)
commitment. The participatory planning group will meet
at least every 6months or at shorter intervals, if required.
using the MrC framework for designing complex
interventions
The Medical Research Council (MRC) four-stage framework consisting of ‘develop-test-evaluate-implement’ will
be used as an underlying framework for researching
complex interventions. Before embarking on a full RCT,
preparatory and exploratory studies may be required to
gradually refine the study design.33 To develop an acceptable, effective and sustainable complex intervention, key
elements are proposed.34 The present project proposal
addresses the ‘development’ stage of the MRC framework
to design an intervention on a theoretical base prior to
its preliminary testing in an exploratory trial (figure 1).
Essentially, in the development stage, a paper-based
exercise will be undertaken dealing with issues such as:
the specific content of the intervention, who will deliver
it, how long it will take to deliver, what each stakeholder
will actually do as part of the intervention, and should the
intervention prove effective, how it may be implemented
into routine practice to increase the likelihood of its
adoption by patients and health services. Providing robust
answers to the above questions is of paramount importance to avoid what Chalmers and Glasziou35 referred to as
‘research waste’, that is, research where insufficient effort
has been made to develop and pilot test the intervention before proceeding to a full RCT. However, since the
MRC framework provides no specific guidance on how to
link theory and intervention techniques, the Capability,
Opportunity, Motivation (COM-B) model of behaviour23
in combination with the Taxonomy of Behaviour Change
Techniques36 will be employed. To our knowledge,
COM-B is the only model that provides a systematic and
transparent way of identifying target behaviours and techniques judged to be most effective in changing behaviour.
The COM-B model has been applied successfully in intervention development in various health-related contexts
including changing eating behaviours,37 enhancing medication adherence,38 reducing blood pressure-related
disease burden39 or improving hearing aid use in adults.40
To manage the process of developing BCIs in a systematic fashion, our work programme is guided by four stages
following intervention mapping.41
Stage 1: systematic reviews for extracting desirable/undesirable
behaviours
Based on the findings from our recently completed systematic review and qualitative meta-summary,42 37 statements
of findings pertaining to self-care were identified representing a comprehensive inventory of findings across 31
qualitative (QUAL) reports. However, the evidence from
qualitative enquiries alone might not be satisfactory for
designing sound evidence-based interventions. Thus,
in addition to drawing on our qualitative synthesis we
have identified a comprehensive systematic review and
meta-analysis (QUAN) based on 65 reports describing the
current evidence concerning determinants of self-care in
patients with HF.43 Hence, two up-to-date comprehensive
reviews synthesising qualitative and quantitative studies
will be used to first identify and then extract all factors
(target behaviours) associated with self-care adherence/
non-adherence. Two members of staff will identify and
extract all behaviours associated with adherence/non-adherence to HF self-care independently from each other
and then compare notes to create a final list of common
behaviours from both reviews (QUAN+QUAL). At the
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4 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
end of stage 1, a final list of common factors extracted is
produced in order to map them onto the COM-B model
of behaviour (see stage 2 below).
Stage 2: mapping of extracted behaviours onto the COM-B
behaviour model
The application of underlying behavioural theories is vital
for designing BCIs,44 because theory-driven interventions
are considered superior.45 Because of its successful utilisation in intervention development, the COM-B model will
be used as a universal behavioural theory to enhance the
understanding of causal mechanisms underlying behaviour
change (figure 2). The COM-B model will allow a more
fine-grained analysis of the causes of adherence/non-adherence, so that an intervention can be selected more precisely
to target a particular behaviour. The COM-B model in
combination with the ‘Behaviour Change Wheel’23 is the
centrepiece of designing BCIs. The behaviour change
wheel—consisting of three concentric circles—will aid
in visualising how intrapersonal and/or interpersonal
behaviour can be changed by targeting specific underlying
modifiable mechanisms (figure 3). Thus, each of the factors
identified in stage 1 will be mapped onto the COM-B model
(equals inner circle of the wheel) using the definitions
regarding components and subcomponents as described
below. If there are difficulties in classifying the factors onto
the COM-B model, a second opinion will be obtained until
a clear assignment can be made. We are aware that not
all factors identified from the literature review will fit into
exactly one subcomponent since the effects of the factors
might work via a number of components.38 This, however,
should not be considered as a limitation of the model
because the effects of the factors are explained by components within the model. For quality assurance, all factors
mapped onto the COM-B model will be double-checked for
accuracy by a research team member not involved in the
mapping exercise.
The COM-B model assists in understanding behaviour
and as such will provide an explanation for why patients
with HF adhere and/or non-adhere to self-care. The
COM-B model consists of three components: (1) capability, (2) opportunity and (3) motivation (COM) that
causes the performance of behaviour (B) and in turn
influences these three components.
To capture important distinctions, the three components are further divided into two subcomponents
each. ‘Capability’ is subdivided into psychological capability (the capacity to engage in the necessary thought
processes) and physical capability (the capacity to engage
in necessary physical processes).23 Psychological capability includes the comprehension of the disease and
its treatment, cognitive functioning such as the capacity
for judgement, thinking or memory as well as executive
function like the capacity to plan.38 Physical capability
involves the capacity to adapt to lifestyle changes such as
Figure 1 Key elements of the MRC framework for developing complex interventions.38 MRC, Medical Research Council.
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 5
Open access
a diet or social behaviours as well as dexterity.38 ‘Opportunity’ is subdivided into physical opportunity (provided
by the environment) and social opportunity (provided by
the cultural milieu that dictates the way we think about
things).23 Physical opportunity includes cost, access (eg,
availability of a weighing scale), regimen complexity,
social support as well as healthcare professional–patient
relationship and communication.38 Social opportunity
comprises the stigma of the disease, the fear of disclosure
as well as religious and/or cultural beliefs.38 ‘Motivation’
is subdivided into reflective processes (involving plans and
evaluations) and automatic processes (involving emotions
and impulses that arise from associative learning and/or
innate dispositions).23 Reflective motivation entails the
perception of the illness (eg, cause, chronic vs acute),
beliefs about treatment (eg, necessity, efficacy, concerns
Figure 2 Application of the COM-B model to self-care adherence.42 COM-B, Capability, Opportunity, Motivation and
Behaviour.
Figure 3 The behaviour change wheel.23 30
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6 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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about current or future adverse events), outcome expectancies as well as self-efficacy.38 Automatic motivation
contains stimuli or cues for action as well as mood state
or mood disorder such as depression and anxiety.38 At the
end of stage 2, all factors (target behaviours) are mapped
onto the COM-B model in order to identify behaviour
change techniques appropriate for modifying behaviours
(see stage 3 below).
Stage 3: mapping of target behaviours onto behaviour change
techniques
In the next step, we will identify behaviour change techniques that are appropriate for changing undesirable
behaviours associated with self-care non-adherence or
to reinforce desirable behaviours associated with selfcare adherence using the behaviour change wheel
(figure 3). The middle circle of the ‘behaviour change
wheel’ contains a choice of nine evidence-based intervention functions that are aimed at addressing the
target behaviours identified with the help of the COM-B
model in stage 2. Please note that the outer circle of the
wheel represents policy categories that will apply less to
behavioural change in the individual.
In order to develop approaches for change,
the Taxonomy of Behaviour Change Techniques
(BCTs) developed by Michie et al36 44 or the concepts
described by Bartholomew et al41 will be used to allow
effective mapping of factors onto behaviour change
techniques to address specific behavioural determinants.
According to Michie,46 a BCT is defined as
an active component of an intervention designed to
change behaviour. The defining characteristics of a
BCT are that it is ‘observable, replicable, irreducible’,
a component of an intervention designed to change
behaviour and a postulated active ingredient within
the intervention. It is thus the smallest component
compatible with retaining the postulated active ingredients, that is, the proposed mechanisms of change,
and can be used alone or in combination with other
BCTs. (p. 182)
The Taxonomy of BCTs was developed in a series of
consensus exercises involving over 50 behaviour change
experts from various disciplines and countries. It contains
93 itemised health BCTs that are clustered into 16 groupings; each group containing between 3 and 11 reliable,
distinct BCTs. This cross-domain taxonomy applies to a
wide range of behaviours and various types of interventions and enjoys international acceptance and use. We will
use this taxonomy for the systematic specification of BCIs.
For example, if a patient has difficulties interpreting his
or her symptoms or attributes them to existing comorbidities, medication side effects or emotional responses,
then a technique that targets to change psychological
capability should be selected. A respective intervention
might involve techniques such as shaping knowledge or
feedback and monitoring.36 The full range of all BCTs
available is depicted by Michie et al36 including examples
of how BCTs can be implemented and information on
how to operationalise BCTs. At the end of stage 3, BCTs
are formulated in order to identify relevant factors that
allow its successful implementation into routine clinical
work (see stage 4 below).
Stage 4: identifying wider factors that influence successful
implementation of BCIs into practice
This stage involves the consultation of intended participants and implementers to identify wider relevant
factors needed for successful implementation of BCIs
into routine work. Suggested BCIs will be translated into
locally relevant interventions using the Normalisation
Process Theory (NPT) to overcome the difficulties of
implementing theoretically derived interventions into
everyday practice.47 48 NPT will be used to identify factors
that individuals and groups need to do in order to enable
true integration of BCIs designed in stage 3 into routine
work.49 To promote adoption and faithful delivery of our
interventions in the future, it is crucial to involve all stakeholders in determining the intervention content and the
best way to deliver it.50 NPT will provide guiding questions for qualitative interviews with key stakeholders that
will shed light on a range of relevant contextual issues48
necessary to increase practical effectiveness, that is,
whether the intervention will work in clinical practice.51
Consequently, NPT assists in better defining the core
components of the intervention and to examine acceptability to patients, their families and health professionals.
Qualitative semistructured interviews with approximately 15–17 key stakeholders, that is, those targeted
by the intervention or involved in its development
or delivery, will be conducted using NPT to guide the
interview questions. Potential participants (eg, patients
with HF, health professionals, academics and so on) will
be identified by the participatory planning group (see
above) to ensure that all relevant stakeholders are represented and their views and preferences are sought. Participants will be contacted by the researcher to arrange for
the interview. Interviews will be conducted in places that
are convenient for the stakeholders according to their
preferences. As described by Lovell et al,52 guiding interview questions will cover the four components of NPT,
that is, (1) questions considering meaning and sense
making by stakeholders (coherence); (2) commitment
and engagement by stakeholders (cognitive participation); (3) the work stakeholders do to make the intervention function (collective action) and (4) stakeholders
appraising the intervention (reflexive monitoring). In
addition, interviews will allow reflection on, and refinement of, content and acceptability of BCTs as well as
specific information regarding the following eight
descriptors suggested for the standardised description
of BCIs: (1) content or elements of the intervention;
(2) characteristics of self-care tutors (eg, health professionals, lay tutors); (3) characteristics of the target population (eg, adults, children); (4) delivery location (eg,
hospital, GP practice, home environment); (5) mode
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 7
Open access
of delivery (eg, group-based, individual approach); (6)
format (eg, lectures, manual); (7) intensity (eg, contact
time) and (8) duration (eg, number of sessions over a
given period).53
Participating key stakeholders will be asked for consent
to the interview. All interviews will be audio recorded
and transcribed verbatim; specific details will be anonymised. Qualitative data will be analysed using thematic
analysis.54 To assure validity, interview texts will be analysed in a multidisciplinary team by reading the transcripts
and identifying emerging themes and categories. Analysis of the data will be informed by the aforementioned
four components of the NPT framework. Regarding
the eight descriptors, in addition to obtaining information from our stakeholders through qualitative enquiry,
we will also retrieve and summarise, if available, specific
HF self-care-related evidence from previously published
quantitative reviews. For example, is there any evidence
that supports the effectiveness of either group-based or
individual approaches (mode of delivery) in enhancing
self-care in patients with HF? The results of the reviews, if
any, will be combined with the individual responses from
the key stakeholders on a matrix; any ambiguities will
be addressed with the help of a consensus development
method (Delphi technique) in order to achieve clarity
concerning the descriptors.
Finally, the Delphi technique—a formal consensus
development research method—involving all key stakeholders will be used to elicit consensus. All stakeholders
will receive an invitation to participate, detailing the
rationale for the consensus exercise. A matrix of the
combined results and a copy of the Delphi questionnaire
will be circulated. Stakeholders who will not respond
within 4weeks will receive a follow-up invitation. The
matrix will serve as a platform for discussion to derive
the final intervention manual. The Delphi questionnaire
will deal specifically with the mixed responses (ambiguities) that remain regarding the descriptors. The process
of collating and distributing an anonymised summary of
the stakeholders’ responses and adjusting earlier answers
based on feedback from the group will be repeated for
a maximum of three rounds. In line with the recommendations by Diamond et al,55 consensus will be a priori
operationalised as a proportion of participants agreeing
to a particular descriptor. For example, the threshold for
determination of consensus might be set at 75% of participating stakeholders.56 If, however, consensus values for
certain descriptors will remain below the prespecified
threshold after the third iteration, a rank order will be
used instead giving preference to the descriptor with the
highest degree of agreement. In summary, the Delphi
technique will aid in fine-tuning our BCIs to increase the
likelihood of its acceptance. At the end of stage 4, we will
have produced a final version of the intervention manual
containing well-defined theory-based BCIs including the
concept and outline of an exploratory trial ready for pilot
testing in a subsequent full randomised controlled intervention trial.
dIsCussIon
The main outcome of this study is to produce a detailed
intervention manual that contains well-defined (ie, using
the eight descriptors suggested for the standardised
description of interventions) theory-based (ie, based
on the COM-B behaviour model) BCIs. Following the
MRC framework for designing complex interventions,
the envisaged subsequent studies encompass: (1) the
execution of an exploratory trial, and if feasible, (2) the
completion of a full RCT. Within the scope of an exploratory trial, the feasibility and acceptance of the actual
intervention described in the manual will be pilot tested.
Particular emphasis will be placed on recruitment strategies, estimates of recruitment numbers, collaborating
institutions or issues concerning the identification of
specific outcome measures for a full RCT. Finally, an
economic evaluation in the form of a cost-effectiveness
analysis will be conducted as part of evaluating the BCIs
compared with an appropriate alternative. Therefore, the
design of a health economic evaluation (eg, cost-effectiveness analysis, cost-utility analysis) from both a societal and
a statutory health insurance perspective will be developed
and appropriate measures for effects and costs defined as
well as instruments for data collection.
strengths and limitations of this study
All BCIs are based on a sound theoretical framework.
Besides that, continuous consultation with potential key
stakeholders, that is, end users and healthcare providers,
will inform intervention development to ensure successful
implementation of BCIs into practice. Furthermore, the
final intervention manual will contain specific information regarding the eight descriptors suggested for the
standardised description of BCIs to allow for replication. However, the execution of a full RCT design is not
possible within the study budget and time frame, but this
current study will collect important data to inform a fullscale RCT in the future.
Ethics and dissemination
The findings of the study will be disseminated through
peer-reviewed journal articles, national and international conference presentations and stakeholder engagement activities (ie, via our participatory planning group
members).
Contributors ORH: designed the study and drafted the manuscript. SS, LA and SW:
provided valuable input in designing the study and critically reviewed and edited
the manuscript. All authors read and approved the final manuscript.
Funding This work was supported by the German Research Foundation (Deutsche
Forschungsgemeinschaft, DFG); grant number HE 7352/1-2.
disclaimer This study’s contents are solely the responsibility of the authors and
do not necessarily represent the official view of DFG. The funding body had no
involvement in the design of the study and will not be involved in the conduct of the
study including data collection, analysis and interpretation of data and in writing
manuscripts for publication.
Competing interests None declared.
Ethics approval Ethics Committee of the Medical Faculty of Heinrich Heine
University, Düsseldorf, Germany (Ref #: 2018-30).
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8 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 1
Open access
Enhancing self-care adherence in
patients with heart failure: a study
protocol for developing a theory-based
behaviour change intervention using the
COM-B behaviour model (ACHIEVE
study)
Oliver Rudolf Herber,1 Louise Atkins,2 Stefan Störk,3 Stefan Wilm1
To cite: Herber OR, Atkins L,
Störk S, et al. Enhancing
self-care adherence in
patients with heart failure: a
study protocol for developing
a theory-based behaviour
change intervention using
the COM-B behaviour model
(ACHIEVE study). BMJ Open
2018;8:e025907. doi:10.1136/
bmjopen-2018-025907
► Prepublication history for
this paper is available online.
To view these files, please visit
the journal online (http://dx.doi.
org/10.1136/bmjopen-2018-
025907).
Received 7 August 2018
Revised 13 August 2018
Accepted 14 August 2018
1
Institute of General Practice
(ifam), Medical Faculty of
the Heinrich Heine University
Düsseldorf, Düsseldorf, Germany
2
UCL Centre for Behaviour
Change, University College
London, London, UK
3
Division of Cardiology at the
Outpatient Clinic of Medical
Department, Comprehensive
Heart Failure Center (CHFC),
University Hospital Würzburg,
Würzburg, Germany
Correspondence to
Dr Oliver Rudolf Herber;
Oliver.Herber@med.uniduesseldorf.de
Protocol
© Author(s) (or their
employer(s)) 2018. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
AbstrACt
Introduction Although international guidelines
recommend self-care as an integral part of routine heart
failure management, and despite evidence supporting
the positive outcomes related to self-care, patients are
frequently unable to adhere. Self-care can be modified
through behaviour change interventions (BCIs). However,
previous self-care interventions have shown limited
success in improving adherence to self-care, because
they were neither theory-based nor well defined,
which precludes the identification of underlying causal
mechanisms as well as reproducibility of the intervention.
Thus, our aim is to develop an intervention manual
that contains theory-based BCIs that are well-defined
using eight descriptors proposed to describe BCIs in a
standardised way.
Methods and analysis BCIs will be based on statements
of findings derived through qualitative meta-summary
techniques and a quantitative meta-analysis. These
reviews will be used to extract factors (target behaviours)
associated with self-care adherence/non-adherence.
Extracted target behaviours will be mapped onto the
‘Capability, Opportunity, Motivation and Behaviour’
(COM-B) model to capture the underlying mechanisms
involved. To develop approaches for change, the
‘Taxonomy of Behaviour Change Techniques’ will be used
to allow effective mapping of the target behaviours onto
established behaviour change techniques. Suggested
BCIs will then be translated into locally relevant
interventions using the Normalisation Process Theory to
overcome the difficulties of implementing theoretically
derived interventions into practice. Finally, a consensus
development method will be employed to fine-tune the
content and acceptability of the intervention manual
to increase the likelihood of successfully piloting and
implementing future BCIs into the German healthcare
system.
Ethics and dissemination This study has been
reviewed and approved by the Ethics Committee of
the Medical Faculty of the Heinrich Heine University
Düsseldorf, Germany (Ref #: 2018-30). The results will
be disseminated via peer-reviewed journal publications,
conference presentations and stakeholder engagement
activities.
trial registration number DRKS00014855; Pre-results.
IntroduCtIon
Heart failure (HF) is a major clinical and public
health problem worldwide associated with
significant healthcare expenditure, morbidity
and mortality.1 In Germany, the prevalence
of HF is estimated at 3%–4%among adults
and increases steeply with age.1Heart failure
is the most common cause of hospital admissions of patients and ranks third as cause of
death.1 Treatment costs are strongly driven
by expenditure for repeated hospitalisations
and increase with disease progression.2 Thus,
HF represents a growing public health and
health economic issue as the population ages.
On an individual level, patients with HF experience physical and psychological distress
such as fatigue, dyspnoea, pain, depression
or problems regarding concentration, all of
strengths and limitations of this study
► Behaviour change intervention (BCI) is based on
sound theoretical framework.
► Extensive consultation with potential key stakeholders, that is, end users and healthcare providers, will
inform intervention development.
► Final intervention manual will contain specific information regarding eight descriptors suggested
for the standardised description of BCIs to allow for
replication.
► Full randomised controlled trial (RCT) design not
possible within the study budget and time frame,
but study will collect important data to inform a fullscale RCT in the future.
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2 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
which are having a major negative impact on the person’s
quality of life.3
After being diagnosed with HF, the prognosis depends
on two major components: one is physician-based and
encompasses all aspects of appropriate treatment, monitoring of effects and communicating relevant information; the other is patient-based and refers to the
concept of self-care including the motivation to adhere
to diagnostic and therapeutic recommendations. HF
care should be exerted in a multidisciplinary team and
involves a patient-centred approach seeking to systematically develop emotional, physical, intellectual and
social resources of the patient.4 Ultimately, such strategy
is thought to empower patients in order to improve and
sustain efficacious self-care behaviour. The term self-care
refers to
the individual’s ability to manage the symptoms, treatment, physical and psychosocial consequences and
life style changes inherent in living with a chronic
condition. Efficacious self-care encompasses the ability to monitor one’s condition and to effect the cognitive, behavioural and emotional responses necessary
to maintain a satisfactory quality of life.5 (p. 178)
Since 2008, the European Guidelines for Diagnosis and
Treatment of HF strongly emphasise self-care (Grade IA
recommendation) as part of routine HF management
and patient empowerment.4 6
Generally, self-care mandates a sustained effort in order
to impact on any chronic disease. In particular, successful
HF therapy requires a substantial amount of self-care and
adherence to multiple aspects of the treatment regimen.7
For example, HF self-care encompasses a complex set of
behaviours including daily weighing, low-sodium diet,
fluid restriction, regular physical exercise, medication
taking, symptom monitoring involving exercising and
developing an awareness of exacerbating symptoms such
as shortness of breath, lower extremity oedema, fatigue or
activity intolerance.8 Hence, such adherence to HF selfcare is considered key in order to achieve a positive effect
on disease progression. Adherence is defined as the extent
to which a patient’s behaviour coincides with the recommendations made by healthcare providers.9 The concept
of adherence focuses on specific patient behaviours
emphasising the need for agreement between patient
and healthcare provider. Sound evidence from systematic reviews has shown that adherence to self-care significantly reduces HF-related hospitalisations,10 morbidity
and mortality,11 decreases hospital readmissions12 and
improves HF-related quality of life.13 Conversely, failure
to adhere to recommended self-care is associated with HF
exacerbation,14 frequent hospital readmissions and low
survival.15
Patients with HF are faced with the difficulty of
adopting complex recommendations including adherence to multiple aspects of the treatment regimen and
lifestyle adjustments in order to prevent disease progression. Self-management interventions aiming at improving
self-care generally seek to empower individuals by
endowing them with the skills necessary to actively participate in the management of their chronic condition.5
Several systematic reviews investigating the efficacy and
effectiveness of self-management interventions involving
home and/or clinic visits, education sessions (eg, ‘giving
information’), telemonitoring approaches and follow-up
telephone calls for patients with HF have been published
to date showing inconsistent results. Earlier conducted
systematic reviews had suggested a relevant benefit in relation to hard clinical endpoints including all-cause hospitalisation and HF-related hospitalisations.12 16 Despite
favourable pooled effects, some more recently conducted
large randomised controlled trials (RCTs) including
multisite studies showed inconsistent results.17–20 Thus,
the effectiveness of self-management interventions in
terms of all-cause hospitalisation, HF-related hospitalisations and death remains inconclusive until today. Part of
this heterogeneity may be attributable to the absence of
self-management interventions applying behaviour strategies and/or cognitive behavioural strategies (rather than
simply educational interventions), insufficient use of
theoretical models underpinning the intervention or lack
of detailed description of the active ingredient(s) driving
the intervention.
In more detail, evidence of grade A (high quality)
exists that interventions using established, well-defined
behaviour change techniques (ie, the ‘active ingredient’
of an intervention) are most effective.21 Yet, a review of
self-management interventions promoting self-care of
patients with HF came to the conclusion that only very
few studies used explicit theory-based interventions, while
the majority still lacked specificity of the mechanisms
employed to improve self-care.22 Such critique was also
articulated by Michie and colleagues,23 who stated that
interventions are commonly designed without applying
an evidence-based underlying model. Instead, interventions are frequently based on implicit common sense
models.24 Similarly, a most recent critical reflection on
methodological challenges encountered in meta-analyses
on self-care interventions advised intervention designers
to pay particular attention to the causal mechanisms
underlying the intervention when designing studies.25
Hence, absent effects of previous self-management interventions seeking to improve self-care may very well be
attributable to the lack of theoretical underpinning or
the use of ill-chosen strategies.26 27
Another criticism relates to the lack of detailed description of the active ingredient(s) driving a successful
intervention. Detailed descriptions are of paramount
importance for replication, allowing scientists to accumulate evidence about intervention effects and causal
mechanisms.28 For the results to be judged, reproducible, sufficiently detailed information must be provided
to allow the potential for reproducing the same or similar
results.29 Yet, specific features rendering interventions
successful are often ill-defined in research publications,
which limit reproducibility.18 Hence, a systematic method
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 3
Open access
that incorporates a thorough understanding of the nature
of the behaviour to be changed (ie, the target behaviour),
an appropriate system for characterising interventions
and their components as well as descriptors suggested for
the standardisation of reporting behaviour change interventions (BCIs) are mandatory. In this way, a ‘science of
change’ can be established in which effective interventions can be understood and replicated.30
In summary, it can be stated that inconclusive results of
existing self-management interventions for patients with
HF may very well be attributable to the absence of interventions applying behaviour strategies and/or cognitive
behavioural strategies, insufficient use of theoretical
models underpinning the intervention or lack of detailed
description of the active ingredient(s) driving the intervention, thus emphasising the need to design an intervention that allows for these likely sources of heterogeneity.
Therefore, the aim of this study is to develop well-defined
theory-based BCIs based on an underlying behaviour
model that allows for identifying effective behaviour
change techniques.
MEthods And AnAlysIs
Patient and public involvement
Our research question emerged from the findings of
published literature on self-management interventions as
described above. Patients and the public are involved in
this early stage of designing BCIs through their involvement as members of the participatory planning group.
To facilitate successful completion of each stage of the
proposed work programme as described below, a participatory planning group will be established right at the
beginning of the study. Intervention development and
implementation should be based on meaningful participation of key stakeholders.31 Thus, for the life of this
project, a participatory planning group will be deployed
to assist in the development of an intervention manual
containing well-defined theory-based BCIs. The planning group will be composed of key stakeholders who
have a particular interest in designing BCIs including
intervention developers, intervention implementers and
intervention end users (ie, patients with HF). For identifying key stakeholders, we will be using the guiding questions proposed by Preskill and Jones.32 They consider
the following five domains to be relevant for the selection process: (1) expertise, (2) diverse perspectives,
(3) responsibility and authority, (4) influence and (5)
commitment. The participatory planning group will meet
at least every 6months or at shorter intervals, if required.
using the MrC framework for designing complex
interventions
The Medical Research Council (MRC) four-stage framework consisting of ‘develop-test-evaluate-implement’ will
be used as an underlying framework for researching
complex interventions. Before embarking on a full RCT,
preparatory and exploratory studies may be required to
gradually refine the study design.33 To develop an acceptable, effective and sustainable complex intervention, key
elements are proposed.34 The present project proposal
addresses the ‘development’ stage of the MRC framework
to design an intervention on a theoretical base prior to
its preliminary testing in an exploratory trial (figure 1).
Essentially, in the development stage, a paper-based
exercise will be undertaken dealing with issues such as:
the specific content of the intervention, who will deliver
it, how long it will take to deliver, what each stakeholder
will actually do as part of the intervention, and should the
intervention prove effective, how it may be implemented
into routine practice to increase the likelihood of its
adoption by patients and health services. Providing robust
answers to the above questions is of paramount importance to avoid what Chalmers and Glasziou35 referred to as
‘research waste’, that is, research where insufficient effort
has been made to develop and pilot test the intervention before proceeding to a full RCT. However, since the
MRC framework provides no specific guidance on how to
link theory and intervention techniques, the Capability,
Opportunity, Motivation (COM-B) model of behaviour23
in combination with the Taxonomy of Behaviour Change
Techniques36 will be employed. To our knowledge,
COM-B is the only model that provides a systematic and
transparent way of identifying target behaviours and techniques judged to be most effective in changing behaviour.
The COM-B model has been applied successfully in intervention development in various health-related contexts
including changing eating behaviours,37 enhancing medication adherence,38 reducing blood pressure-related
disease burden39 or improving hearing aid use in adults.40
To manage the process of developing BCIs in a systematic fashion, our work programme is guided by four stages
following intervention mapping.41
Stage 1: systematic reviews for extracting desirable/undesirable
behaviours
Based on the findings from our recently completed systematic review and qualitative meta-summary,42 37 statements
of findings pertaining to self-care were identified representing a comprehensive inventory of findings across 31
qualitative (QUAL) reports. However, the evidence from
qualitative enquiries alone might not be satisfactory for
designing sound evidence-based interventions. Thus,
in addition to drawing on our qualitative synthesis we
have identified a comprehensive systematic review and
meta-analysis (QUAN) based on 65 reports describing the
current evidence concerning determinants of self-care in
patients with HF.43 Hence, two up-to-date comprehensive
reviews synthesising qualitative and quantitative studies
will be used to first identify and then extract all factors
(target behaviours) associated with self-care adherence/
non-adherence. Two members of staff will identify and
extract all behaviours associated with adherence/non-adherence to HF self-care independently from each other
and then compare notes to create a final list of common
behaviours from both reviews (QUAN+QUAL). At the
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4 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
end of stage 1, a final list of common factors extracted is
produced in order to map them onto the COM-B model
of behaviour (see stage 2 below).
Stage 2: mapping of extracted behaviours onto the COM-B
behaviour model
The application of underlying behavioural theories is vital
for designing BCIs,44 because theory-driven interventions
are considered superior.45 Because of its successful utilisation in intervention development, the COM-B model will
be used as a universal behavioural theory to enhance the
understanding of causal mechanisms underlying behaviour
change (figure 2). The COM-B model will allow a more
fine-grained analysis of the causes of adherence/non-adherence, so that an intervention can be selected more precisely
to target a particular behaviour. The COM-B model in
combination with the ‘Behaviour Change Wheel’23 is the
centrepiece of designing BCIs. The behaviour change
wheel—consisting of three concentric circles—will aid
in visualising how intrapersonal and/or interpersonal
behaviour can be changed by targeting specific underlying
modifiable mechanisms (figure 3). Thus, each of the factors
identified in stage 1 will be mapped onto the COM-B model
(equals inner circle of the wheel) using the definitions
regarding components and subcomponents as described
below. If there are difficulties in classifying the factors onto
the COM-B model, a second opinion will be obtained until
a clear assignment can be made. We are aware that not
all factors identified from the literature review will fit into
exactly one subcomponent since the effects of the factors
might work via a number of components.38 This, however,
should not be considered as a limitation of the model
because the effects of the factors are explained by components within the model. For quality assurance, all factors
mapped onto the COM-B model will be double-checked for
accuracy by a research team member not involved in the
mapping exercise.
The COM-B model assists in understanding behaviour
and as such will provide an explanation for why patients
with HF adhere and/or non-adhere to self-care. The
COM-B model consists of three components: (1) capability, (2) opportunity and (3) motivation (COM) that
causes the performance of behaviour (B) and in turn
influences these three components.
To capture important distinctions, the three components are further divided into two subcomponents
each. ‘Capability’ is subdivided into psychological capability (the capacity to engage in the necessary thought
processes) and physical capability (the capacity to engage
in necessary physical processes).23 Psychological capability includes the comprehension of the disease and
its treatment, cognitive functioning such as the capacity
for judgement, thinking or memory as well as executive
function like the capacity to plan.38 Physical capability
involves the capacity to adapt to lifestyle changes such as
Figure 1 Key elements of the MRC framework for developing complex interventions.38 MRC, Medical Research Council.
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 5
Open access
a diet or social behaviours as well as dexterity.38 ‘Opportunity’ is subdivided into physical opportunity (provided
by the environment) and social opportunity (provided by
the cultural milieu that dictates the way we think about
things).23 Physical opportunity includes cost, access (eg,
availability of a weighing scale), regimen complexity,
social support as well as healthcare professional–patient
relationship and communication.38 Social opportunity
comprises the stigma of the disease, the fear of disclosure
as well as religious and/or cultural beliefs.38 ‘Motivation’
is subdivided into reflective processes (involving plans and
evaluations) and automatic processes (involving emotions
and impulses that arise from associative learning and/or
innate dispositions).23 Reflective motivation entails the
perception of the illness (eg, cause, chronic vs acute),
beliefs about treatment (eg, necessity, efficacy, concerns
Figure 2 Application of the COM-B model to self-care adherence.42 COM-B, Capability, Opportunity, Motivation and
Behaviour.
Figure 3 The behaviour change wheel.23 30
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6 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
about current or future adverse events), outcome expectancies as well as self-efficacy.38 Automatic motivation
contains stimuli or cues for action as well as mood state
or mood disorder such as depression and anxiety.38 At the
end of stage 2, all factors (target behaviours) are mapped
onto the COM-B model in order to identify behaviour
change techniques appropriate for modifying behaviours
(see stage 3 below).
Stage 3: mapping of target behaviours onto behaviour change
techniques
In the next step, we will identify behaviour change techniques that are appropriate for changing undesirable
behaviours associated with self-care non-adherence or
to reinforce desirable behaviours associated with selfcare adherence using the behaviour change wheel
(figure 3). The middle circle of the ‘behaviour change
wheel’ contains a choice of nine evidence-based intervention functions that are aimed at addressing the
target behaviours identified with the help of the COM-B
model in stage 2. Please note that the outer circle of the
wheel represents policy categories that will apply less to
behavioural change in the individual.
In order to develop approaches for change,
the Taxonomy of Behaviour Change Techniques
(BCTs) developed by Michie et al36 44 or the concepts
described by Bartholomew et al41 will be used to allow
effective mapping of factors onto behaviour change
techniques to address specific behavioural determinants.
According to Michie,46 a BCT is defined as
an active component of an intervention designed to
change behaviour. The defining characteristics of a
BCT are that it is ‘observable, replicable, irreducible’,
a component of an intervention designed to change
behaviour and a postulated active ingredient within
the intervention. It is thus the smallest component
compatible with retaining the postulated active ingredients, that is, the proposed mechanisms of change,
and can be used alone or in combination with other
BCTs. (p. 182)
The Taxonomy of BCTs was developed in a series of
consensus exercises involving over 50 behaviour change
experts from various disciplines and countries. It contains
93 itemised health BCTs that are clustered into 16 groupings; each group containing between 3 and 11 reliable,
distinct BCTs. This cross-domain taxonomy applies to a
wide range of behaviours and various types of interventions and enjoys international acceptance and use. We will
use this taxonomy for the systematic specification of BCIs.
For example, if a patient has difficulties interpreting his
or her symptoms or attributes them to existing comorbidities, medication side effects or emotional responses,
then a technique that targets to change psychological
capability should be selected. A respective intervention
might involve techniques such as shaping knowledge or
feedback and monitoring.36 The full range of all BCTs
available is depicted by Michie et al36 including examples
of how BCTs can be implemented and information on
how to operationalise BCTs. At the end of stage 3, BCTs
are formulated in order to identify relevant factors that
allow its successful implementation into routine clinical
work (see stage 4 below).
Stage 4: identifying wider factors that influence successful
implementation of BCIs into practice
This stage involves the consultation of intended participants and implementers to identify wider relevant
factors needed for successful implementation of BCIs
into routine work. Suggested BCIs will be translated into
locally relevant interventions using the Normalisation
Process Theory (NPT) to overcome the difficulties of
implementing theoretically derived interventions into
everyday practice.47 48 NPT will be used to identify factors
that individuals and groups need to do in order to enable
true integration of BCIs designed in stage 3 into routine
work.49 To promote adoption and faithful delivery of our
interventions in the future, it is crucial to involve all stakeholders in determining the intervention content and the
best way to deliver it.50 NPT will provide guiding questions for qualitative interviews with key stakeholders that
will shed light on a range of relevant contextual issues48
necessary to increase practical effectiveness, that is,
whether the intervention will work in clinical practice.51
Consequently, NPT assists in better defining the core
components of the intervention and to examine acceptability to patients, their families and health professionals.
Qualitative semistructured interviews with approximately 15–17 key stakeholders, that is, those targeted
by the intervention or involved in its development
or delivery, will be conducted using NPT to guide the
interview questions. Potential participants (eg, patients
with HF, health professionals, academics and so on) will
be identified by the participatory planning group (see
above) to ensure that all relevant stakeholders are represented and their views and preferences are sought. Participants will be contacted by the researcher to arrange for
the interview. Interviews will be conducted in places that
are convenient for the stakeholders according to their
preferences. As described by Lovell et al,52 guiding interview questions will cover the four components of NPT,
that is, (1) questions considering meaning and sense
making by stakeholders (coherence); (2) commitment
and engagement by stakeholders (cognitive participation); (3) the work stakeholders do to make the intervention function (collective action) and (4) stakeholders
appraising the intervention (reflexive monitoring). In
addition, interviews will allow reflection on, and refinement of, content and acceptability of BCTs as well as
specific information regarding the following eight
descriptors suggested for the standardised description
of BCIs: (1) content or elements of the intervention;
(2) characteristics of self-care tutors (eg, health professionals, lay tutors); (3) characteristics of the target population (eg, adults, children); (4) delivery location (eg,
hospital, GP practice, home environment); (5) mode
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 7
Open access
of delivery (eg, group-based, individual approach); (6)
format (eg, lectures, manual); (7) intensity (eg, contact
time) and (8) duration (eg, number of sessions over a
given period).53
Participating key stakeholders will be asked for consent
to the interview. All interviews will be audio recorded
and transcribed verbatim; specific details will be anonymised. Qualitative data will be analysed using thematic
analysis.54 To assure validity, interview texts will be analysed in a multidisciplinary team by reading the transcripts
and identifying emerging themes and categories. Analysis of the data will be informed by the aforementioned
four components of the NPT framework. Regarding
the eight descriptors, in addition to obtaining information from our stakeholders through qualitative enquiry,
we will also retrieve and summarise, if available, specific
HF self-care-related evidence from previously published
quantitative reviews. For example, is there any evidence
that supports the effectiveness of either group-based or
individual approaches (mode of delivery) in enhancing
self-care in patients with HF? The results of the reviews, if
any, will be combined with the individual responses from
the key stakeholders on a matrix; any ambiguities will
be addressed with the help of a consensus development
method (Delphi technique) in order to achieve clarity
concerning the descriptors.
Finally, the Delphi technique—a formal consensus
development research method—involving all key stakeholders will be used to elicit consensus. All stakeholders
will receive an invitation to participate, detailing the
rationale for the consensus exercise. A matrix of the
combined results and a copy of the Delphi questionnaire
will be circulated. Stakeholders who will not respond
within 4weeks will receive a follow-up invitation. The
matrix will serve as a platform for discussion to derive
the final intervention manual. The Delphi questionnaire
will deal specifically with the mixed responses (ambiguities) that remain regarding the descriptors. The process
of collating and distributing an anonymised summary of
the stakeholders’ responses and adjusting earlier answers
based on feedback from the group will be repeated for
a maximum of three rounds. In line with the recommendations by Diamond et al,55 consensus will be a priori
operationalised as a proportion of participants agreeing
to a particular descriptor. For example, the threshold for
determination of consensus might be set at 75% of participating stakeholders.56 If, however, consensus values for
certain descriptors will remain below the prespecified
threshold after the third iteration, a rank order will be
used instead giving preference to the descriptor with the
highest degree of agreement. In summary, the Delphi
technique will aid in fine-tuning our BCIs to increase the
likelihood of its acceptance. At the end of stage 4, we will
have produced a final version of the intervention manual
containing well-defined theory-based BCIs including the
concept and outline of an exploratory trial ready for pilot
testing in a subsequent full randomised controlled intervention trial.
dIsCussIon
The main outcome of this study is to produce a detailed
intervention manual that contains well-defined (ie, using
the eight descriptors suggested for the standardised
description of interventions) theory-based (ie, based
on the COM-B behaviour model) BCIs. Following the
MRC framework for designing complex interventions,
the envisaged subsequent studies encompass: (1) the
execution of an exploratory trial, and if feasible, (2) the
completion of a full RCT. Within the scope of an exploratory trial, the feasibility and acceptance of the actual
intervention described in the manual will be pilot tested.
Particular emphasis will be placed on recruitment strategies, estimates of recruitment numbers, collaborating
institutions or issues concerning the identification of
specific outcome measures for a full RCT. Finally, an
economic evaluation in the form of a cost-effectiveness
analysis will be conducted as part of evaluating the BCIs
compared with an appropriate alternative. Therefore, the
design of a health economic evaluation (eg, cost-effectiveness analysis, cost-utility analysis) from both a societal and
a statutory health insurance perspective will be developed
and appropriate measures for effects and costs defined as
well as instruments for data collection.
strengths and limitations of this study
All BCIs are based on a sound theoretical framework.
Besides that, continuous consultation with potential key
stakeholders, that is, end users and healthcare providers,
will inform intervention development to ensure successful
implementation of BCIs into practice. Furthermore, the
final intervention manual will contain specific information regarding the eight descriptors suggested for the
standardised description of BCIs to allow for replication. However, the execution of a full RCT design is not
possible within the study budget and time frame, but this
current study will collect important data to inform a fullscale RCT in the future.
Ethics and dissemination
The findings of the study will be disseminated through
peer-reviewed journal articles, national and international conference presentations and stakeholder engagement activities (ie, via our participatory planning group
members).
Contributors ORH: designed the study and drafted the manuscript. SS, LA and SW:
provided valuable input in designing the study and critically reviewed and edited
the manuscript. All authors read and approved the final manuscript.
Funding This work was supported by the German Research Foundation (Deutsche
Forschungsgemeinschaft, DFG); grant number HE 7352/1-2.
disclaimer This study’s contents are solely the responsibility of the authors and
do not necessarily represent the official view of DFG. The funding body had no
involvement in the design of the study and will not be involved in the conduct of the
study including data collection, analysis and interpretation of data and in writing
manuscripts for publication.
Competing interests None declared.
Ethics approval Ethics Committee of the Medical Faculty of Heinrich Heine
University, Düsseldorf, Germany (Ref #: 2018-30).
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8 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
Open access
Provenance and peer review Not commissioned; peer reviewed for ethical and
funding approval prior to submission.
open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 1
Open access
Enhancing self-care adherence in
patients with heart failure: a study
protocol for developing a theory-based
behaviour change intervention using the
COM-B behaviour model (ACHIEVE
study)
Oliver Rudolf Herber,1 Louise Atkins,2 Stefan Störk,3 Stefan Wilm1
To cite: Herber OR, Atkins L,
Störk S, et al. Enhancing
self-care adherence in
patients with heart failure: a
study protocol for developing
a theory-based behaviour
change intervention using
the COM-B behaviour model
(ACHIEVE study). BMJ Open
2018;8:e025907. doi:10.1136/
bmjopen-2018-025907
► Prepublication history for
this paper is available online.
To view these files, please visit
the journal online (http://dx.doi.
org/10.1136/bmjopen-2018-
025907).
Received 7 August 2018
Revised 13 August 2018
Accepted 14 August 2018
1
Institute of General Practice
(ifam), Medical Faculty of
the Heinrich Heine University
Düsseldorf, Düsseldorf, Germany
2
UCL Centre for Behaviour
Change, University College
London, London, UK
3
Division of Cardiology at the
Outpatient Clinic of Medical
Department, Comprehensive
Heart Failure Center (CHFC),
University Hospital Würzburg,
Würzburg, Germany
Correspondence to
Dr Oliver Rudolf Herber;
Oliver.Herber@med.uniduesseldorf.de
Protocol
© Author(s) (or their
employer(s)) 2018. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
AbstrACt
Introduction Although international guidelines
recommend self-care as an integral part of routine heart
failure management, and despite evidence supporting
the positive outcomes related to self-care, patients are
frequently unable to adhere. Self-care can be modified
through behaviour change interventions (BCIs). However,
previous self-care interventions have shown limited
success in improving adherence to self-care, because
they were neither theory-based nor well defined,
which precludes the identification of underlying causal
mechanisms as well as reproducibility of the intervention.
Thus, our aim is to develop an intervention manual
that contains theory-based BCIs that are well-defined
using eight descriptors proposed to describe BCIs in a
standardised way.
Methods and analysis BCIs will be based on statements
of findings derived through qualitative meta-summary
techniques and a quantitative meta-analysis. These
reviews will be used to extract factors (target behaviours)
associated with self-care adherence/non-adherence.
Extracted target behaviours will be mapped onto the
‘Capability, Opportunity, Motivation and Behaviour’
(COM-B) model to capture the underlying mechanisms
involved. To develop approaches for change, the
‘Taxonomy of Behaviour Change Techniques’ will be used
to allow effective mapping of the target behaviours onto
established behaviour change techniques. Suggested
BCIs will then be translated into locally relevant
interventions using the Normalisation Process Theory to
overcome the difficulties of implementing theoretically
derived interventions into practice. Finally, a consensus
development method will be employed to fine-tune the
content and acceptability of the intervention manual
to increase the likelihood of successfully piloting and
implementing future BCIs into the German healthcare
system.
Ethics and dissemination This study has been
reviewed and approved by the Ethics Committee of
the Medical Faculty of the Heinrich Heine University
Düsseldorf, Germany (Ref #: 2018-30). The results will
be disseminated via peer-reviewed journal publications,
conference presentations and stakeholder engagement
activities.
trial registration number DRKS00014855; Pre-results.
IntroduCtIon
Heart failure (HF) is a major clinical and public
health problem worldwide associated with
significant healthcare expenditure, morbidity
and mortality.1 In Germany, the prevalence
of HF is estimated at 3%–4%among adults
and increases steeply with age.1Heart failure
is the most common cause of hospital admissions of patients and ranks third as cause of
death.1 Treatment costs are strongly driven
by expenditure for repeated hospitalisations
and increase with disease progression.2 Thus,
HF represents a growing public health and
health economic issue as the population ages.
On an individual level, patients with HF experience physical and psychological distress
such as fatigue, dyspnoea, pain, depression
or problems regarding concentration, all of
strengths and limitations of this study
► Behaviour change intervention (BCI) is based on
sound theoretical framework.
► Extensive consultation with potential key stakeholders, that is, end users and healthcare providers, will
inform intervention development.
► Final intervention manual will contain specific information regarding eight descriptors suggested
for the standardised description of BCIs to allow for
replication.
► Full randomised controlled trial (RCT) design not
possible within the study budget and time frame,
but study will collect important data to inform a fullscale RCT in the future.
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2 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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which are having a major negative impact on the person’s
quality of life.3
After being diagnosed with HF, the prognosis depends
on two major components: one is physician-based and
encompasses all aspects of appropriate treatment, monitoring of effects and communicating relevant information; the other is patient-based and refers to the
concept of self-care including the motivation to adhere
to diagnostic and therapeutic recommendations. HF
care should be exerted in a multidisciplinary team and
involves a patient-centred approach seeking to systematically develop emotional, physical, intellectual and
social resources of the patient.4 Ultimately, such strategy
is thought to empower patients in order to improve and
sustain efficacious self-care behaviour. The term self-care
refers to
the individual’s ability to manage the symptoms, treatment, physical and psychosocial consequences and
life style changes inherent in living with a chronic
condition. Efficacious self-care encompasses the ability to monitor one’s condition and to effect the cognitive, behavioural and emotional responses necessary
to maintain a satisfactory quality of life.5 (p. 178)
Since 2008, the European Guidelines for Diagnosis and
Treatment of HF strongly emphasise self-care (Grade IA
recommendation) as part of routine HF management
and patient empowerment.4 6
Generally, self-care mandates a sustained effort in order
to impact on any chronic disease. In particular, successful
HF therapy requires a substantial amount of self-care and
adherence to multiple aspects of the treatment regimen.7
For example, HF self-care encompasses a complex set of
behaviours including daily weighing, low-sodium diet,
fluid restriction, regular physical exercise, medication
taking, symptom monitoring involving exercising and
developing an awareness of exacerbating symptoms such
as shortness of breath, lower extremity oedema, fatigue or
activity intolerance.8 Hence, such adherence to HF selfcare is considered key in order to achieve a positive effect
on disease progression. Adherence is defined as the extent
to which a patient’s behaviour coincides with the recommendations made by healthcare providers.9 The concept
of adherence focuses on specific patient behaviours
emphasising the need for agreement between patient
and healthcare provider. Sound evidence from systematic reviews has shown that adherence to self-care significantly reduces HF-related hospitalisations,10 morbidity
and mortality,11 decreases hospital readmissions12 and
improves HF-related quality of life.13 Conversely, failure
to adhere to recommended self-care is associated with HF
exacerbation,14 frequent hospital readmissions and low
survival.15
Patients with HF are faced with the difficulty of
adopting complex recommendations including adherence to multiple aspects of the treatment regimen and
lifestyle adjustments in order to prevent disease progression. Self-management interventions aiming at improving
self-care generally seek to empower individuals by
endowing them with the skills necessary to actively participate in the management of their chronic condition.5
Several systematic reviews investigating the efficacy and
effectiveness of self-management interventions involving
home and/or clinic visits, education sessions (eg, ‘giving
information’), telemonitoring approaches and follow-up
telephone calls for patients with HF have been published
to date showing inconsistent results. Earlier conducted
systematic reviews had suggested a relevant benefit in relation to hard clinical endpoints including all-cause hospitalisation and HF-related hospitalisations.12 16 Despite
favourable pooled effects, some more recently conducted
large randomised controlled trials (RCTs) including
multisite studies showed inconsistent results.17–20 Thus,
the effectiveness of self-management interventions in
terms of all-cause hospitalisation, HF-related hospitalisations and death remains inconclusive until today. Part of
this heterogeneity may be attributable to the absence of
self-management interventions applying behaviour strategies and/or cognitive behavioural strategies (rather than
simply educational interventions), insufficient use of
theoretical models underpinning the intervention or lack
of detailed description of the active ingredient(s) driving
the intervention.
In more detail, evidence of grade A (high quality)
exists that interventions using established, well-defined
behaviour change techniques (ie, the ‘active ingredient’
of an intervention) are most effective.21 Yet, a review of
self-management interventions promoting self-care of
patients with HF came to the conclusion that only very
few studies used explicit theory-based interventions, while
the majority still lacked specificity of the mechanisms
employed to improve self-care.22 Such critique was also
articulated by Michie and colleagues,23 who stated that
interventions are commonly designed without applying
an evidence-based underlying model. Instead, interventions are frequently based on implicit common sense
models.24 Similarly, a most recent critical reflection on
methodological challenges encountered in meta-analyses
on self-care interventions advised intervention designers
to pay particular attention to the causal mechanisms
underlying the intervention when designing studies.25
Hence, absent effects of previous self-management interventions seeking to improve self-care may very well be
attributable to the lack of theoretical underpinning or
the use of ill-chosen strategies.26 27
Another criticism relates to the lack of detailed description of the active ingredient(s) driving a successful
intervention. Detailed descriptions are of paramount
importance for replication, allowing scientists to accumulate evidence about intervention effects and causal
mechanisms.28 For the results to be judged, reproducible, sufficiently detailed information must be provided
to allow the potential for reproducing the same or similar
results.29 Yet, specific features rendering interventions
successful are often ill-defined in research publications,
which limit reproducibility.18 Hence, a systematic method
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 3
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that incorporates a thorough understanding of the nature
of the behaviour to be changed (ie, the target behaviour),
an appropriate system for characterising interventions
and their components as well as descriptors suggested for
the standardisation of reporting behaviour change interventions (BCIs) are mandatory. In this way, a ‘science of
change’ can be established in which effective interventions can be understood and replicated.30
In summary, it can be stated that inconclusive results of
existing self-management interventions for patients with
HF may very well be attributable to the absence of interventions applying behaviour strategies and/or cognitive
behavioural strategies, insufficient use of theoretical
models underpinning the intervention or lack of detailed
description of the active ingredient(s) driving the intervention, thus emphasising the need to design an intervention that allows for these likely sources of heterogeneity.
Therefore, the aim of this study is to develop well-defined
theory-based BCIs based on an underlying behaviour
model that allows for identifying effective behaviour
change techniques.
MEthods And AnAlysIs
Patient and public involvement
Our research question emerged from the findings of
published literature on self-management interventions as
described above. Patients and the public are involved in
this early stage of designing BCIs through their involvement as members of the participatory planning group.
To facilitate successful completion of each stage of the
proposed work programme as described below, a participatory planning group will be established right at the
beginning of the study. Intervention development and
implementation should be based on meaningful participation of key stakeholders.31 Thus, for the life of this
project, a participatory planning group will be deployed
to assist in the development of an intervention manual
containing well-defined theory-based BCIs. The planning group will be composed of key stakeholders who
have a particular interest in designing BCIs including
intervention developers, intervention implementers and
intervention end users (ie, patients with HF). For identifying key stakeholders, we will be using the guiding questions proposed by Preskill and Jones.32 They consider
the following five domains to be relevant for the selection process: (1) expertise, (2) diverse perspectives,
(3) responsibility and authority, (4) influence and (5)
commitment. The participatory planning group will meet
at least every 6months or at shorter intervals, if required.
using the MrC framework for designing complex
interventions
The Medical Research Council (MRC) four-stage framework consisting of ‘develop-test-evaluate-implement’ will
be used as an underlying framework for researching
complex interventions. Before embarking on a full RCT,
preparatory and exploratory studies may be required to
gradually refine the study design.33 To develop an acceptable, effective and sustainable complex intervention, key
elements are proposed.34 The present project proposal
addresses the ‘development’ stage of the MRC framework
to design an intervention on a theoretical base prior to
its preliminary testing in an exploratory trial (figure 1).
Essentially, in the development stage, a paper-based
exercise will be undertaken dealing with issues such as:
the specific content of the intervention, who will deliver
it, how long it will take to deliver, what each stakeholder
will actually do as part of the intervention, and should the
intervention prove effective, how it may be implemented
into routine practice to increase the likelihood of its
adoption by patients and health services. Providing robust
answers to the above questions is of paramount importance to avoid what Chalmers and Glasziou35 referred to as
‘research waste’, that is, research where insufficient effort
has been made to develop and pilot test the intervention before proceeding to a full RCT. However, since the
MRC framework provides no specific guidance on how to
link theory and intervention techniques, the Capability,
Opportunity, Motivation (COM-B) model of behaviour23
in combination with the Taxonomy of Behaviour Change
Techniques36 will be employed. To our knowledge,
COM-B is the only model that provides a systematic and
transparent way of identifying target behaviours and techniques judged to be most effective in changing behaviour.
The COM-B model has been applied successfully in intervention development in various health-related contexts
including changing eating behaviours,37 enhancing medication adherence,38 reducing blood pressure-related
disease burden39 or improving hearing aid use in adults.40
To manage the process of developing BCIs in a systematic fashion, our work programme is guided by four stages
following intervention mapping.41
Stage 1: systematic reviews for extracting desirable/undesirable
behaviours
Based on the findings from our recently completed systematic review and qualitative meta-summary,42 37 statements
of findings pertaining to self-care were identified representing a comprehensive inventory of findings across 31
qualitative (QUAL) reports. However, the evidence from
qualitative enquiries alone might not be satisfactory for
designing sound evidence-based interventions. Thus,
in addition to drawing on our qualitative synthesis we
have identified a comprehensive systematic review and
meta-analysis (QUAN) based on 65 reports describing the
current evidence concerning determinants of self-care in
patients with HF.43 Hence, two up-to-date comprehensive
reviews synthesising qualitative and quantitative studies
will be used to first identify and then extract all factors
(target behaviours) associated with self-care adherence/
non-adherence. Two members of staff will identify and
extract all behaviours associated with adherence/non-adherence to HF self-care independently from each other
and then compare notes to create a final list of common
behaviours from both reviews (QUAN+QUAL). At the
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4 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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end of stage 1, a final list of common factors extracted is
produced in order to map them onto the COM-B model
of behaviour (see stage 2 below).
Stage 2: mapping of extracted behaviours onto the COM-B
behaviour model
The application of underlying behavioural theories is vital
for designing BCIs,44 because theory-driven interventions
are considered superior.45 Because of its successful utilisation in intervention development, the COM-B model will
be used as a universal behavioural theory to enhance the
understanding of causal mechanisms underlying behaviour
change (figure 2). The COM-B model will allow a more
fine-grained analysis of the causes of adherence/non-adherence, so that an intervention can be selected more precisely
to target a particular behaviour. The COM-B model in
combination with the ‘Behaviour Change Wheel’23 is the
centrepiece of designing BCIs. The behaviour change
wheel—consisting of three concentric circles—will aid
in visualising how intrapersonal and/or interpersonal
behaviour can be changed by targeting specific underlying
modifiable mechanisms (figure 3). Thus, each of the factors
identified in stage 1 will be mapped onto the COM-B model
(equals inner circle of the wheel) using the definitions
regarding components and subcomponents as described
below. If there are difficulties in classifying the factors onto
the COM-B model, a second opinion will be obtained until
a clear assignment can be made. We are aware that not
all factors identified from the literature review will fit into
exactly one subcomponent since the effects of the factors
might work via a number of components.38 This, however,
should not be considered as a limitation of the model
because the effects of the factors are explained by components within the model. For quality assurance, all factors
mapped onto the COM-B model will be double-checked for
accuracy by a research team member not involved in the
mapping exercise.
The COM-B model assists in understanding behaviour
and as such will provide an explanation for why patients
with HF adhere and/or non-adhere to self-care. The
COM-B model consists of three components: (1) capability, (2) opportunity and (3) motivation (COM) that
causes the performance of behaviour (B) and in turn
influences these three components.
To capture important distinctions, the three components are further divided into two subcomponents
each. ‘Capability’ is subdivided into psychological capability (the capacity to engage in the necessary thought
processes) and physical capability (the capacity to engage
in necessary physical processes).23 Psychological capability includes the comprehension of the disease and
its treatment, cognitive functioning such as the capacity
for judgement, thinking or memory as well as executive
function like the capacity to plan.38 Physical capability
involves the capacity to adapt to lifestyle changes such as
Figure 1 Key elements of the MRC framework for developing complex interventions.38 MRC, Medical Research Council.
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Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907 5
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a diet or social behaviours as well as dexterity.38 ‘Opportunity’ is subdivided into physical opportunity (provided
by the environment) and social opportunity (provided by
the cultural milieu that dictates the way we think about
things).23 Physical opportunity includes cost, access (eg,
availability of a weighing scale), regimen complexity,
social support as well as healthcare professional–patient
relationship and communication.38 Social opportunity
comprises the stigma of the disease, the fear of disclosure
as well as religious and/or cultural beliefs.38 ‘Motivation’
is subdivided into reflective processes (involving plans and
evaluations) and automatic processes (involving emotions
and impulses that arise from associative learning and/or
innate dispositions).23 Reflective motivation entails the
perception of the illness (eg, cause, chronic vs acute),
beliefs about treatment (eg, necessity, efficacy, concerns
Figure 2 Application of the COM-B model to self-care adherence.42 COM-B, Capability, Opportunity, Motivation and
Behaviour.
Figure 3 The behaviour change wheel.23 30
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6 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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about current or future adverse events), outcome expectancies as well as self-efficacy.38 Automatic motivation
contains stimuli or cues for action as well as mood state
or mood disorder such as depression and anxiety.38 At the
end of stage 2, all factors (target behaviours) are mapped
onto the COM-B model in order to identify behaviour
change techniques appropriate for modifying behaviours
(see stage 3 below).
Stage 3: mapping of target behaviours onto behaviour change
techniques
In the next step, we will identify behaviour change techniques that are appropriate for changing undesirable
behaviours associated with self-care non-adherence or
to reinforce desirable behaviours associated with selfcare adherence using the behaviour change wheel
(figure 3). The middle circle of the ‘behaviour change
wheel’ contains a choice of nine evidence-based intervention functions that are aimed at addressing the
target behaviours identified with the help of the COM-B
model in stage 2. Please note that the outer circle of the
wheel represents policy categories that will apply less to
behavioural change in the individual.
In order to develop approaches for change,
the Taxonomy of Behaviour Change Techniques
(BCTs) developed by Michie et al36 44 or the concepts
described by Bartholomew et al41 will be used to allow
effective mapping of factors onto behaviour change
techniques to address specific behavioural determinants.
According to Michie,46 a BCT is defined as
an active component of an intervention designed to
change behaviour. The defining characteristics of a
BCT are that it is ‘observable, replicable, irreducible’,
a component of an intervention designed to change
behaviour and a postulated active ingredient within
the intervention. It is thus the smallest component
compatible with retaining the postulated active ingredients, that is, the proposed mechanisms of change,
and can be used alone or in combination with other
BCTs. (p. 182)
The Taxonomy of BCTs was developed in a series of
consensus exercises involving over 50 behaviour change
experts from various disciplines and countries. It contains
93 itemised health BCTs that are clustered into 16 groupings; each group containing between 3 and 11 reliable,
distinct BCTs. This cross-domain taxonomy applies to a
wide range of behaviours and various types of interventions and enjoys international acceptance and use. We will
use this taxonomy for the systematic specification of BCIs.
For example, if a patient has difficulties interpreting his
or her symptoms or attributes them to existing comorbidities, medication side effects or emotional responses,
then a technique that targets to change psychological
capability should be selected. A respective intervention
might involve techniques such as shaping knowledge or
feedback and monitoring.36 The full range of all BCTs
available is depicted by Michie et al36 including examples
of how BCTs can be implemented and information on
how to operationalise BCTs. At the end of stage 3, BCTs
are formulated in order to identify relevant factors that
allow its successful implementation into routine clinical
work (see stage 4 below).
Stage 4: identifying wider factors that influence successful
implementation of BCIs into practice
This stage involves the consultation of intended participants and implementers to identify wider relevant
factors needed for successful implementation of BCIs
into routine work. Suggested BCIs will be translated into
locally relevant interventions using the Normalisation
Process Theory (NPT) to overcome the difficulties of
implementing theoretically derived interventions into
everyday practice.47 48 NPT will be used to identify factors
that individuals and groups need to do in order to enable
true integration of BCIs designed in stage 3 into routine
work.49 To promote adoption and faithful delivery of our
interventions in the future, it is crucial to involve all stakeholders in determining the intervention content and the
best way to deliver it.50 NPT will provide guiding questions for qualitative interviews with key stakeholders that
will shed light on a range of relevant contextual issues48
necessary to increase practical effectiveness, that is,
whether the intervention will work in clinical practice.51
Consequently, NPT assists in better defining the core
components of the intervention and to examine acceptability to patients, their families and health professionals.
Qualitative semistructured interviews with approximately 15–17 key stakeholders, that is, those targeted
by the intervention or involved in its development
or delivery, will be conducted using NPT to guide the
interview questions. Potential participants (eg, patients
with HF, health professionals, academics and so on) will
be identified by the participatory planning group (see
above) to ensure that all relevant stakeholders are represented and their views and preferences are sought. Participants will be contacted by the researcher to arrange for
the interview. Interviews will be conducted in places that
are convenient for the stakeholders according to their
preferences. As described by Lovell et al,52 guiding interview questions will cover the four components of NPT,
that is, (1) questions considering meaning and sense
making by stakeholders (coherence); (2) commitment
and engagement by stakeholders (cognitive participation); (3) the work stakeholders do to make the intervention function (collective action) and (4) stakeholders
appraising the intervention (reflexive monitoring). In
addition, interviews will allow reflection on, and refinement of, content and acceptability of BCTs as well as
specific information regarding the following eight
descriptors suggested for the standardised description
of BCIs: (1) content or elements of the intervention;
(2) characteristics of self-care tutors (eg, health professionals, lay tutors); (3) characteristics of the target population (eg, adults, children); (4) delivery location (eg,
hospital, GP practice, home environment); (5) mode
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of delivery (eg, group-based, individual approach); (6)
format (eg, lectures, manual); (7) intensity (eg, contact
time) and (8) duration (eg, number of sessions over a
given period).53
Participating key stakeholders will be asked for consent
to the interview. All interviews will be audio recorded
and transcribed verbatim; specific details will be anonymised. Qualitative data will be analysed using thematic
analysis.54 To assure validity, interview texts will be analysed in a multidisciplinary team by reading the transcripts
and identifying emerging themes and categories. Analysis of the data will be informed by the aforementioned
four components of the NPT framework. Regarding
the eight descriptors, in addition to obtaining information from our stakeholders through qualitative enquiry,
we will also retrieve and summarise, if available, specific
HF self-care-related evidence from previously published
quantitative reviews. For example, is there any evidence
that supports the effectiveness of either group-based or
individual approaches (mode of delivery) in enhancing
self-care in patients with HF? The results of the reviews, if
any, will be combined with the individual responses from
the key stakeholders on a matrix; any ambiguities will
be addressed with the help of a consensus development
method (Delphi technique) in order to achieve clarity
concerning the descriptors.
Finally, the Delphi technique—a formal consensus
development research method—involving all key stakeholders will be used to elicit consensus. All stakeholders
will receive an invitation to participate, detailing the
rationale for the consensus exercise. A matrix of the
combined results and a copy of the Delphi questionnaire
will be circulated. Stakeholders who will not respond
within 4weeks will receive a follow-up invitation. The
matrix will serve as a platform for discussion to derive
the final intervention manual. The Delphi questionnaire
will deal specifically with the mixed responses (ambiguities) that remain regarding the descriptors. The process
of collating and distributing an anonymised summary of
the stakeholders’ responses and adjusting earlier answers
based on feedback from the group will be repeated for
a maximum of three rounds. In line with the recommendations by Diamond et al,55 consensus will be a priori
operationalised as a proportion of participants agreeing
to a particular descriptor. For example, the threshold for
determination of consensus might be set at 75% of participating stakeholders.56 If, however, consensus values for
certain descriptors will remain below the prespecified
threshold after the third iteration, a rank order will be
used instead giving preference to the descriptor with the
highest degree of agreement. In summary, the Delphi
technique will aid in fine-tuning our BCIs to increase the
likelihood of its acceptance. At the end of stage 4, we will
have produced a final version of the intervention manual
containing well-defined theory-based BCIs including the
concept and outline of an exploratory trial ready for pilot
testing in a subsequent full randomised controlled intervention trial.
dIsCussIon
The main outcome of this study is to produce a detailed
intervention manual that contains well-defined (ie, using
the eight descriptors suggested for the standardised
description of interventions) theory-based (ie, based
on the COM-B behaviour model) BCIs. Following the
MRC framework for designing complex interventions,
the envisaged subsequent studies encompass: (1) the
execution of an exploratory trial, and if feasible, (2) the
completion of a full RCT. Within the scope of an exploratory trial, the feasibility and acceptance of the actual
intervention described in the manual will be pilot tested.
Particular emphasis will be placed on recruitment strategies, estimates of recruitment numbers, collaborating
institutions or issues concerning the identification of
specific outcome measures for a full RCT. Finally, an
economic evaluation in the form of a cost-effectiveness
analysis will be conducted as part of evaluating the BCIs
compared with an appropriate alternative. Therefore, the
design of a health economic evaluation (eg, cost-effectiveness analysis, cost-utility analysis) from both a societal and
a statutory health insurance perspective will be developed
and appropriate measures for effects and costs defined as
well as instruments for data collection.
strengths and limitations of this study
All BCIs are based on a sound theoretical framework.
Besides that, continuous consultation with potential key
stakeholders, that is, end users and healthcare providers,
will inform intervention development to ensure successful
implementation of BCIs into practice. Furthermore, the
final intervention manual will contain specific information regarding the eight descriptors suggested for the
standardised description of BCIs to allow for replication. However, the execution of a full RCT design is not
possible within the study budget and time frame, but this
current study will collect important data to inform a fullscale RCT in the future.
Ethics and dissemination
The findings of the study will be disseminated through
peer-reviewed journal articles, national and international conference presentations and stakeholder engagement activities (ie, via our participatory planning group
members).
Contributors ORH: designed the study and drafted the manuscript. SS, LA and SW:
provided valuable input in designing the study and critically reviewed and edited
the manuscript. All authors read and approved the final manuscript.
Funding This work was supported by the German Research Foundation (Deutsche
Forschungsgemeinschaft, DFG); grant number HE 7352/1-2.
disclaimer This study’s contents are solely the responsibility of the authors and
do not necessarily represent the official view of DFG. The funding body had no
involvement in the design of the study and will not be involved in the conduct of the
study including data collection, analysis and interpretation of data and in writing
manuscripts for publication.
Competing interests None declared.
Ethics approval Ethics Committee of the Medical Faculty of Heinrich Heine
University, Düsseldorf, Germany (Ref #: 2018-30).
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8 Herber OR, et al. BMJ Open 2018;8:e025907. doi:10.1136/bmjopen-2018-025907
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Provenance and peer review Not commissioned; peer reviewed for ethical and
funding approval prior to submission.
open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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