Digital health interventions (DHIs) are increasingly becoming integrated into diabetes self-management to improve behavior. Despite DHIs becoming available to people with chronic conditions, the development strategies and processes undertaken are often not well described. With theoretical frameworks available in current literature, it is vital that DHIs follow a shared language and communicate a robust development process in a comprehensive way. This paper aims to bring a unique perspective to digital development, as it describes the systematic process of developing a digital self-management program for people with type 2 diabetes, MyDESMOND. We provide a step-by-step guide, based on the intervention mapping (IM) framework to illustrate the process of adapting an existing face-to-face self-management program (diabetes education and self- management for ongoing and newly diagnosed, DESMOND) and translating it to a digital platform (MyDESMOND). Overall, this paper describes the 4 IM steps that were followed to develop MyDESMOND—step 1 to establish a planning group and a patient and public involvement group to describe the context of the intervention and program goals, step 2 to identify objectives and determinants at early design stages to maintain a focus on the strategies adopted, step 3 to generate the program components underpinned by appropriate psychological theories and models, and step 4 to develop the program content and describe the iterative process of refining the content and format of the digital program for implementation. This paper concludes with a number of key learnings collated throughout our development process, which we hope other researchers may find useful when developing DHIs for chronic conditions.
The pandemic has presented unique challenges for people with diabetes, who comprise a high risk group for severe COVID‐19 infection(1–3). There has been increased emphasis on the importance of self‐care activities for people with diabetes to optimise their diabetes management; however, this has proven difficult because of restrictions due to lockdown and reduced face‐to‐face diabetes education (4). Nevertheless, the pandemic has also presented people with diabetes and their healthcare teams with an opportunity to innovate and move quickly towards increasingly digitalised care, to continue supporting people with diabetes from their own homes.
BackgroundA diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM.MethodsThe study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation.DiscussionIf effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D.Trial registrationISRCTN, ISRCTN17299860. Registered on 5 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3067-8) contains supplementary material, which is available to authorized users.
BackgroundCoronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehabilitation optimises patient outcomes. However, a high percentage of these services do not meet necessary performance indicators such as course length and follow-up attendance. Uptake of such services is only 50% in UK patients and support provided 12 months after an event is often limited. To delay and prevent further CHD events leading to hospitalisation, supplementary self-management strategies such as group education, are necessary.MethodsThis is a single-centre, randomised controlled trial (RCT) recruiting participants (n = 290) aged ≥18 years who are 12 to 48 months post diagnosis of a CHD-related cardiac event (myocardial infarction, angina and any other acute coronary syndrome). The study aims to implement a structured education programme, with text-message support over 12 months, and identify whether delivery of the programme, to individuals who have a history of a cardiac event, would be an effective and cost-effective strategy for increasing walking. The primary outcome, objectively measured average daily physical activity, specifically step count through walking activity, is assessed using the wrist-worn GENEActiv accelerometer at baseline, 6 and 12 months. Secondary outcomes at 12 months include cardiovascular risk factors such as smoking status, blood pressure, lipid profile, glycated haemoglobin (HbA1c), obesity, self-efficacy, quality of life, physical activity and physical function.Participants are randomised to either the control group receiving standard care and a physical activity information leaflet, or the intervention group whose partcipants receive the leaflet and are invited to attend two group-based structured education sessions. These encourage participants to adopt and maintain healthy behaviours and self-manage their lifestyle. They are delivered approximately 2 weeks apart by trained facilitators and reinforced via subsequent text-message support.DiscussionTo our knowledge, this is the first trial designed to assess the effectiveness of a group education programme 12 to 48 months after a CHD event diagnosis. If successful, the PACES programme could be translated into effective post-operative cardiac care and complement the current post-operative services available.Trial registrationISRCTN, ID: ISRCTN91163727. The trial was registered on 27 February 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2923-x) contains supplementary material, which is available to authorized users.
Background Health care self-management is important for people living with nondialysis chronic kidney disease (CKD). However, the few available resources are of variable quality. Objective This work describes the systematic codevelopment of “My Kidneys & Me” (MK&M), a theory-driven and evidence-based digital self-management resource for people with nondialysis CKD, guided by an established process used for the successful development of the diabetes education program MyDESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed, DESMOND). Methods A multidisciplinary steering group comprising kidney health care professionals and researchers and specialists in the development of complex interventions and digital health provided expertise in the clinical and psychosocial aspects of CKD, self-management, digital health, and behavior change. A patient and public involvement group helped identify the needs and priorities of MK&M and co-design the resource. MK&M was developed in 2 sequential phases. Phase 1 involved the codevelopment process of the MK&M resource (content and materials), using Intervention Mapping (IM) as a framework. The first 4 IM steps guided the development process: needs assessment was conducted to describe the context of the intervention; intervention outcomes, performance objectives, and behavioral determinants were identified; theory- and evidence-based change methods and practical strategies to deliver change methods were selected; and program components were developed and refined. Phase 2 involved the adoption and adaptation of the existing MyDESMOND digital platform to suit the MK&M resource. Results The needs assessment identified that individuals with CKD have multiple differing needs and that delivering a self-management program digitally would enable accessible, tailored, and interactive information and support. The intended outcomes of MK&M were to improve and maintain effective self-management behaviors, including physical activity and lifestyle, improve knowledge, promote self-care skills, increase self-efficacy, and enhance well-being. This was achieved through the provision of content and materials designed to increase CKD knowledge and patient activation, reduce health risks, manage symptoms, and improve physical function. Theories and behavior change techniques selected include Self-Management Framework, Capability, Opportunity, Motivation Behavior model components of Behaviour Change Wheel and taxonomy of behavior change techniques, Health Action Process Approach Model, Common Sense Model, and Social Cognitive Theory. The program components developed comprised educational and behavior change sessions, health trackers (eg, monitoring blood pressure, symptoms, and exercise), goal-setting features, and forums for social support. The MyDESMOND digital platform represented an ideal existing platform to host MK&M; thus, the MyDESMOND interface and features were adopted and adapted for MK&M. Conclusions Applying the IM framework enabled the systematic application of theory, empirical evidence, and practical perspectives in the codevelopment of MK&M content and materials. Adopting and adapting a preexisting platform provided a cost- and time-efficient approach for developing our digital intervention. In the next stage of work, the efficacy of MK&M in increasing patient activation will be tested in a randomized controlled trial.
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