None listed
Conditions
Brief summary
Web and mobile applications are increasingly being used as self-management tools to improve outcomes for patients with long term conditions including diabetes. However, research regarding their effectiveness is still evolving. When effective, these tools (often in the form of live chat, a text reminder service, or a functional application) are a way in which less reliance can be ultimately placed on the health systems and patients can be empowered to increasingly self-manage. An innovative digital health programme has been developed aimed at supporting prevention and self-management of diabetes and prediabetes. This programme, called BetaMe, is delivered via a web and mobile-based platform, integrates with primary care providers and utilises social/peer support, health coaches, health tracking, behaviour change tools and engaging content that drives behaviour change. The aim of this research is to assess the effectiveness of this intervention in reversing pre-diabetes and improving the self-management of diabetes compared with usual care in a primary care setting. People with diabetes and prediabetes who meet our inclusion criteria will be randomly assigned to be enrolled in the BetaMe programme or to receive usual care. Our primary outcomes will be a change in HbA1C (a measure of diabetes control) and weight at 12 months after enrolling in the study compared with at baseline. We will also assess changes in weight circumference, blood pressure, self-efficacy, diabetes-specific healthy behaviours and outcomes, quality of life in changes to diabetes-related medications at 4 and 12 months compared with at baseline.
Interventions
The intervention for this study is the BetaMe programme, which is an integrative evidence-based self-management programme for type two diabetes mellitus (T2DM) and prediabetes. Melon Health Ltd has been subcontracted to deliver the BetaMe programme to those in the intervention arm of the trial. Those randomised to the intervention arm will be enrolled on the BetaMe programme. It consists of four separate components; health coaches, provision of evidence-based resources, goal tracking and peer support. BetaMe is internet-based and delivered using both mobile and web-based platforms. Initiating the BetaMe programme: Those participants randomised to the BetaMe programme (intervention arm) will be contacted by a health coach within ten working days of having their baseline blood test taken. The health coach will provide detail for patients to access an online tutorial about the BetaMe programme, including a short video orientating participants to the app and how to use it. Health coaching: The health coaches are all either qualified personal trainers or registered nurses trained in motivational interviewing, cognitive behavioural therapy, and nutrition, and have completed the Heart Foundation Pacific Heartbeat Community Nutrition course. Health coaches will arrange the first one-on-one session with participants. The purpose of this first session which is one-hour is so that health coaches can work with participants to develop goals that are tailored according to their needs and values. The session follows a set format. Coaches use a number of standard conversation starters, and activities to work through with participants to establish what their values are, in order to develop goals that are relevant and meaningful to them. Maori and Pacific coaches will be available. Once these goals have been set and agreed on, participants’ goals are entered into their profile on the BetaMe system. Coaches will then continue to work with participants. Coaches will message participants weekly to check on their progress, reinforce information from the modules and arrange further meetings at frequencies that suit the participant (these can be weekly or fortnightly or less frequently if preferred). These subsequent meetings are around 15-20 ins in length. All meetings with the coaches will be by audio or video, as per the participant’s preference. Participants are able to make appointments with or send messages to their coach through the BetaMe app. Clinical Governance of the health coaches will be provided by a health psychologist, who will spend one-on-one time with each coach on a fortnightly basis. Coaches will have access to a range of coaching resources , and will be supported by the project mental health lead (a general practitioner) and an experienced health coach. Coaches also regularly interact with one another via an online forum (separate from patient forums) to share any problems they are having and solutions. Health literacy: There are eight key education modules introduced to participants through an introduction to the module via the web and mobile platform with attached resources (videos, infographics, articles, tips, tools, meal ideas and mini-quiz). The time spent on the modules is up to the participant, but would typically be less than two hours. The key messages in the modules are also reinforced in corresponding email newsletters, discussions on the newsfeed initiated by the Community Manager and by the participant’s coach. Every two weeks, a new module is released that presents participants with a range of topics that offer key messages to help them to learn about and manage their own health. The modules are: Week 0: Introduction to BetaMe and risk factors of prediabetes and Diabetes. Week 1-2: Healthy Eating, Healthy Moving. Week 3-4: Triggers and Habits. Week 5: Review your progress. Week 6-7: Eating for Health. Week 8-9: Drinks, Sleep and Shift Work. Week 10: Recap & Refresh, Week 11-12: Problem Solving. Week 13-14: Healthy Coping & Mindfulness. Week 15-16: Reflection and Celebration. The content of these modules aligns with the Ministry of Health Guidelines for health eating and the Heart Foundation guidelines. Participants will have the option for one-on-one on-line chats with their coach to discuss each new module. Goal tracking: Participants are encouraged to track their progress towards their goals (including healthy eating, physical activity, weight, happiness and sleep). They will be provided with a set of digital scales and a tape measure so they can take their own measurements and track their progress. They will be able to share these data with their health coach at any time, or with their doctor by email or at their next appointment. Peer support: The programme also includes peer support with real-time chat within a private and secure online social network monitored by a Community Manager who is a registered nurse trained in nutrition. This person monitors the community to ensure nothing unsafe (like personal details, or negative health messages) is shared, and that people are supported and supportive. They will also reinforce key messages, highlight local events in the area, start conversations and welcome new people to the community. Timing of intervention: In the first 16 weeks of the programme, participants will set goals, work with health coaches, receive the evidence-based modules and be encouraged to use goal tracking and participate in the peer support programme. After that time, participants will be encouraged to continue tracking and participating in peer support, for the remainder of the 52-week programme. Information from the modules is available for the entire 52-week period. At the end of the study, there will be a process evaluation which will include assessments of implementation of the BetaMe programme and mechanisms of action. Data will be collected from three sources: 1) from the mobile/web platform to identify key usage patterns; 2) with consent from the participants, health coaches will record audio interactions with participants and will log key reasons for contact (a random subset of the first coaching sessions will be assessed by the research team for consistency with the log); 3) participants will be invited to provide individual feedback on the acceptability and usefulness of the intervention at the end of the study period. Focus groups, lasting approximately one hour each, will be held in each region to obtain in-depth feedback about the intervention and how participants interacted with it. Usage will be described, and linked to outcomes using standard quantitative analytic approaches (for example, proportions accessing health coaches will be reported, with 95% confidence intervals; frequency of accessing health coaches or engaging online will be reported as median access with range/interquartile range). Focus group data will be coded thematically, with key issues identified.
Sponsors
Study design
Eligibility
Inclusion criteria
The study will be based in two regions of New Zealand, Midlands and Greater Wellington. Participating practices are those based in these regions that are interested in being involved in the study and able to commit to the study timeframes and process requirements. Practice recruitment will be through an opt-in process. Patients will be eligible for inclusion if they meet the following inclusion criteria: Have a current HbA1c of 41-70 mmol/mol (either from a test within three months prior to invitation to the study, or on the basis of an HbA1c test taken by the research team at invitation to the study). Are not currently on insulin treatment for diabetes Adults aged between 18-75 years, enrolled in participating primary care practices. Have daily internet access (on any of computer/tablet/smartphone) Are able to provide informed consent.
Exclusion criteria
Patients will not be eligible for the study if they: Are pregnant Have cognitive impairment likely to be sufficient to hinder their understanding of the study or the programme, as this may negatively affect their self-management behaviour.56 Are unable to read and write in English. Unable to use phone or computer due to physical disability such as poor eyesight or manual dexterity.