scholarly journals Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
M. A. Arden ◽  
M. Hutchings ◽  
P. Whelan ◽  
S. J. Drabble ◽  
D. Beever ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Development Strategy ◽  
Treatment Adherence ◽  
Behaviour Change ◽  
Multidisciplinary Team ◽  
Treatment Plan ◽  
Controlled Trial ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques

Abstract Background Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

scholarly journals Development of an intervention to increase adherence to nebuliser treatment in adults with Cystic Fibrosis: CFHealthHub

2020 ◽  
Author(s):  
Madelynne Arden ◽  
Marlene Hutchings ◽  
Pauline Whelan ◽  
Sarah J. Drabble ◽  
Daniel Beever ◽  
...  
Keyword(s):  
Development Strategy ◽  
Treatment Adherence ◽  
Behaviour Change ◽  
Multidisciplinary Team ◽  
Treatment Plan ◽  
Controlled Trial ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques ◽  
Randomised Controlled

BackgroundCystic Fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden.MethodsIntervention development was informed by the behaviour change wheel (BCW) and Person-Based Approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions, and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. ResultsResults indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback, confidence in their ability to adhere, to have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs.ConclusionsThe intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

scholarly journals Developing a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice and subsequently change antibiotic use

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e035793 ◽  
Author(s):  
Marta Santillo ◽  
Marta Wanat ◽  
Mina Davoudianfar ◽  
Emily Bongard ◽  
Sinisa Savic ◽  
...  
Keyword(s):  
General Practice ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Intervention Development ◽  
Penicillin Allergy ◽  
Feasibility Trial ◽  
Rapid Review ◽  
Behavioural Intervention ◽  
Behaviour Change Techniques ◽  
Intervention Package

ObjectivesTo develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result.MethodsTheory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention ‘guiding principles’ and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials.ResultsThe collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers.ConclusionsWe present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.

scholarly journals Do combinations of behaviour change techniques that occur frequently in interventions reflect underlying theory?

2019 ◽  
Author(s):  
Lauren Connell Bohlen ◽  
Susan Michie ◽  
Marijn de Bruin ◽  
Alexander Rothman ◽  
Michael P Kelly ◽  
...  
Keyword(s):  
Factor Analysis ◽  
Behaviour Change ◽  
Change Theory ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques ◽  
Behavioural Interventions ◽  
Behavioral Theories ◽  
Theory Use ◽  
Selection Of

Background: Behavioural interventions typically include multiple behaviour change techniques (BCTs). The theory informing the selection of BCTs for an intervention may be stated explicitly, or remain unreported, thus impeding the identification of links between theory and behaviour change outcomes. Purpose: This study aimed to identify groups of BCTs commonly occurring together in behaviour change interventions and examine whether behaviour change theories underlying these groups could be identified.Methods: The study involved three phases: 1) a factor analysis to identify groups of co-occurring BCTs from 277 behaviour change intervention reports; 2) an expert consensus exercise (n=25) to examine links between BCT groups and behavioral theories; 3) a comparison of the expert-linked theories with theories explicitly mentioned by authors of the 277 intervention reports.Results: Five groups of co-occurring BCTs (range: 3-13 BCTs per group) were identified through factor analysis. Experts agreed on five links (≥80% of experts), comprising three BCT groups and five behaviour change theories. Four of the five BCT Group-theory links agreed by experts were also stated by study authors in intervention reports using similar groups of BCTs.Conclusions: It is possible to identify groups of BCTs frequently used together in interventions. Experts made shared inferences about behaviour change theory underlying these BCT groups, suggesting it may be possible to propose a theoretical basis for interventions where authors do not explicitly put forward a theory. These results advance our understanding of theory use in multi-component interventions and build the evidence base for further understanding theory-based intervention development and evaluation.

Applying the COM-B behaviour model to overcome barriers to heart failure self-care: A practical application of a conceptual framework for the development of complex interventions (ACHIEVE study)

2020 ◽  
pp. 147451512095729
Author(s):  
Amanda Whittal ◽  
Stefan Störk ◽  
Barbara Riegel ◽  
Oliver Rudolf Herber
Keyword(s):  
Heart Failure ◽  
Behaviour Change ◽  
Complex Interventions ◽  
Self Care ◽  
Intervention Development ◽  
Heart Association ◽  
Barriers And Facilitators ◽  
Behaviour Change Techniques ◽  
Anticipated Regret ◽  
Management Interventions

Background: Effective interventions to enhance adherence to self-care recommendations in patients with heart failure have immense potential to improve health and wellbeing. However, there is substantial inconsistency in the effectiveness of existing self-management interventions, partly because they lack theoretical models underpinning intervention development. Aim: To outline how the capability, opportunity and motivation behaviour model has been applied to guide the development of a theory-based intervention aiming to improve adherence to heart failure self-care recommendations. Methods: The application of the capability, opportunity and motivation behaviour model involved three steps: (a) identification of barriers and facilitators to heart failure self-care from two comprehensive meta-studies; (b) identification of appropriate behaviour change techniques to improve heart failure self-care; and (c) involvement of experts to reduce and refine potential behaviour change techniques further. Results: A total of 119 barriers and facilitators were identified. Fifty-six behaviour change techniques remained after applying three steps of the behaviour model for designing interventions. Expert involvement ( n=39, of which 31 were patients (67% men; 45% New York Heart Association II)) further reduced and refined potential behaviour change techniques. Experts disliked some behaviour change techniques such as ‘anticipated regret’ and ‘salience of consequences’. This process resulted in a final comprehensive list consisting of 28 barriers and 49 appropriate behaviour change techniques potentially enhancing self-care that was put forward for further use. Conclusion: The application of the capability, opportunity and motivation behaviour model facilitated identifying important factors influencing adherence to heart failure self-care recommendations. The model served as a comprehensive guide for the selection and design of interventions for improving heart failure self-care adherence. The capability, opportunity and motivation behaviour model enabled the connection of heart failure self-care barriers to particular behaviour change techniques to be used in practice.

scholarly journals A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
D. E. Patton ◽  
J. J. Francis ◽  
E. Clark ◽  
F. Smith ◽  
C. A. Cadogan ◽  
...  
Keyword(s):  
Pilot Study ◽  
Process Evaluation ◽  
Behaviour Change ◽  
Older Patients ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Self Report ◽  
Community Pharmacies ◽  
Behaviour Change Techniques ◽  
Limited Effectiveness

Abstract Background Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Methods As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Discussion Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures. Trial registration This study is registered at ISRCTN: 10.1186/ISRCTN73831533

scholarly journals Implementing the use of objective medication adherence data in routine clinical practice via the digital CFHealthHub platform: situation analysis and strategy development using the theoretical domains framework

2021 ◽  
Author(s):  
Carla Girling ◽  
Anna Packham ◽  
Louisa Robinson ◽  
Madelynne A Arden ◽  
Daniel Hind ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Medication Adherence ◽  
Behaviour Change ◽  
Implementation Strategy ◽  
Clinical Care ◽  
Theoretical Domains Framework ◽  
Behaviour Change Techniques ◽  
Implementation Phase ◽  
Adherence Data ◽  
Healthcare Innovation

Abstract Background Preventative inhaled treatments preserve lung function and reduce exacerbations in Cystic Fibrosis (CF). Self-reported adherence to these treatments is over-estimated. An online platform (CFHealthHub) has been developed with patients and clinicians to display real-time objective adherence data from dose-counting nebulisers, so that clinical teams can offer informed treatment support. Methods In this paper, we identify pre-implementation barriers to healthcare practitioners performing two key behaviours: accessing objective adherence data through the website CFHealthHub and discussing medication adherence with patients. We aimed to understand barriers during the pre-implementation phase, so that appropriate strategy could be developed for the scale up of implementing objective adherence data in 19 CF centres. Thirteen semi-structured interviews were conducted with healthcare practitioners working in three UK CF centres. Qualitative data were coded using the Theoretical Domains Framework (TDF), which describes 14 validated domains to implementation behaviour change. Results Analysis indicated that an implementation strategy should address all 14 domains of the TDF to successfully support implementation. Participants did not report routines or habits for using objective adherence data in clinical care. Examples of salient barriers included skills, beliefs in consequences, and social influence and professional roles. The results also affirmed a requirement to address organisational barriers. Relevant behaviour change techniques were selected to develop implementation strategy modules using the behaviour change wheel approach to intervention development. ConclusionsThis paper demonstrates the value of applying the TDF at pre-implementation, to understand context and to support the development of a situationally relevant implementation strategy. Contribution to the literature· Research indicates that the implementation of healthcare innovations may be more likely to succeed when context and theory are taken into consideration. · In this study, healthcare professionals identified barriers to two behaviours that were key to the implementation of a national Cystic Fibrosis (CF) healthcare innovation. By coding barriers to the Theoretical Domains Framework (TDF), a contextually relevant implementation strategy was developed, with a focus on clinician behaviour change. · The study highlights the challenges CF teams face when implementing new remote monitoring of medication adherence, and provides an important opportunity to apply the TDF in the pre-implementation phase of a healthcare innovation.

scholarly journals Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeremy Horwood ◽  
Melanie Chalder ◽  
Ben Ainsworth ◽  
James Denison-Day ◽  
Frank de Vocht ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Behaviour Change Techniques ◽  
Current Standard ◽  
Link Type ◽  
Implementation Period ◽  
Full Protocol ◽  
Randomised Controlled

Abstract Objectives To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. Trial design A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. Participants Setting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices. Intervention and comparator Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website (http://GermDefence.org/) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users’ personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. Main outcomes The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice Randomisation GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. Blinding (masking) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. Numbers to be randomised (sample size) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. Trial status Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. Trial registration This trial was registered in the ISRCTN registry (isrctn.com/ISRCTN14602359) on 12 August 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Knowing your genes: does this impact behaviour change?

2017 ◽  
Vol 76 (3) ◽  
pp. 182-191 ◽  
Author(s):  
Clare B. O'Donovan ◽  
Marianne C. Walsh ◽  
Michael J. Gibney ◽  
Lorraine Brennan ◽  
Eileen R. Gibney
Keyword(s):  
Behaviour Change ◽  
Research Question ◽  
Evidence Base ◽  
Dietary Advice ◽  
Behaviour Change Techniques ◽  
Dietary Folate ◽  
Genotype Information ◽  
Future Work ◽  
The Impact ◽  
Original Concept

It is postulated that knowledge of genotype may be more powerful than other types of personalised information in terms of motivating behaviour change. However, there is also a danger that disclosure of genetic risk may promote a fatalistic attitude and demotivate individuals. The original concept of personalised nutrition (PN) focused on genotype-based tailored dietary advice; however, PN can also be delivered based on assessment of dietary intake and phenotypic measures. Whilst dietitians currently provide PN advice based on diet and phenotype, genotype-based PN advice is not so readily available. The aim of this review is to examine the evidence for genotype-based personalised information on motivating behaviour change, and factors which may affect the impact of genotype-based personalised advice. Recent findings in PN will also be discussed, with respect to a large European study, Food4Me, which investigated the impact of varying levels of PN advice on motivating behaviour change. The researchers reported that PN advice resulted in greater dietary changes compared with general healthy eating advice, but no additional benefit was observed for PN advice based on phenotype and genotype information. Within Food4Me, work from our group revealed that knowledge of MTHFR genotype did not significantly improve intakes of dietary folate. In general, evidence is weak with regard to genotype-based PN advice. For future work, studies should test the impact of PN advice developed on a strong nutrigenetic evidence base, ensure an appropriate study design for the research question asked, and incorporate behaviour change techniques into the intervention.

scholarly journals Developing a theory-informed complex intervention to improve nurse–patient therapeutic engagement employing Experience-based Co-design and the Behaviour Change Wheel: an acute mental health ward case study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047114
Author(s):  
Sarah McAllister ◽  
Alan Simpson ◽  
Vicki Tsianakas ◽  
Nick Canham ◽  
Vittoria De Meo ◽  
...  
Keyword(s):  
Mental Health ◽  
Behaviour Change ◽  
Design Process ◽  
Complex Interventions ◽  
Intervention Development ◽  
Behaviour Change Techniques ◽  
Service Users ◽  
Therapeutic Engagement ◽  
Behaviour Change Wheel

ObjectivesOur objectives were threefold: (1) describe a collaborative, theoretically driven approach to co-designing complex interventions; (2) demonstrate the implementation of this approach to share learning with others; and (3) develop a toolkit to enhance therapeutic engagement on acute mental health wards.Design and participantsWe describe a theory-driven approach to co-designing an intervention by adapting and integrating Experience-based Co-design (EBCD) with the Behaviour Change Wheel (BCW). Our case study was informed by the results of a systematic integrative review and guided by this integrated approach. We undertook 80 hours of non-participant observations, and semistructured interviews with 14 service users (7 of which were filmed), 2 carers and 12 clinicians from the same acute ward. The facilitated intervention co-design process involved two feedback workshops, one joint co-design workshop and seven small co-design team meetings. Data analysis comprised the identification of touchpoints and use of the BCW and behaviour change technique taxonomy to inform intervention development.SettingThis study was conducted over 12 months at an acute mental health organisation in England.ResultsThe co-designed Let’s Talk toolkit addressed four joint service user/clinician priorities for change: (1) improve communication with withdrawn people; (2) nurses to help service users help themselves; (3) nurses to feel confident when engaging with service users; (4) improving team relations and ward culture. Intervention functions included training, education, enablement, coercion and persuasion; 14 behaviour change techniques supported these functions. We detail how we implemented our integrated co-design-behaviour change approach with service users, carers and clinicians to develop a toolkit to improve nurse–patient therapeutic engagement.ConclusionsOur theory-driven approach enhanced both EBCD and the BCW. It introduces a robust theoretical approach to guide intervention development within the co-design process and sets out how to meaningfully involve service users and other stakeholders when designing and implementing complex interventions.

scholarly journals Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Leon ◽  
Hazel Namadingo ◽  
Kirsty Bobrow ◽  
Sara Cooper ◽  
Amelia Crampin ◽  
...  
Keyword(s):  
Treatment Adherence ◽  
Controlled Trial ◽  
Text Message ◽  
Intervention Development ◽  
Text Messages ◽  
Sub Saharan Africa ◽  
Diabetes Treatment ◽  
Sub Saharan ◽  
Randomised Controlled

Abstract Background Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. Method We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. Results We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808). Conclusion The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

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