Rationale for research
Long-term conditions pose a great burden to patients, whānau and health services. Self-management interventions are a potential way to address this burden with evidence that they can be effective in improving physical and mental health. Important gaps in evidence remain, and are a barrier to implementation. The BetaMe programme is an integrative evidence-based, comprehensive, self-management programme delivered by mobile and web-based technology. The programme, based on behavioural change theory, was developed by a multi-disciplinary team including primary care practitioners, patients, Māori and Pacific experts, health psychologists and diabetes and technology experts based at the Mayo clinic. It incorporates 1. individualised health coaching, 2. goal setting and tracking, 3. peer support in a secure online forum and 4. resources and behaviour change tools. A pilot of 117 pre-diabetic patients was extremely successful with 78% of people reducing their HbA1c level below pre-diabetic range over 4 months.
The overall aims of this project are: 1) to assess the effectiveness, cost-effectiveness, accessibility, acceptability overall, and impact on inequalities in health for Māori of an integrated, comprehensive, patient-centred self-management intervention (BetaMe) in reversing prediabetes and improving the self-management of type 2 diabetes mellitus (T2DM) and, 2) to provide context specific information for decision-makers that will allow the rapid implementation of this programme for local populations.
Research design and methods
The project is divided into three research components and an implementation component. A randomised controlled trial (RCT) will evaluate the effectiveness of the intervention in improving the self-management of T2DM and prediabetes compared with usual care in a primary care setting. The study will run through two PHOs and a Māori Provider (n=430). Eligible participants will be 18-75 years, diabetic or pre-diabetic, with an HBA1C of 45-64 mmol/mol) in the year prior to the study. Eligible participants who consent to participate will be randomised to the control arm (usual care) or intervention arm (usual care and BetaMe). The BetaMe Programme will be delivered by Melon Health, with a 16-week core programme followed by a maintenance period of 36 weeks. A range of outcomes will be assessed at baseline, 4 and 12 months (see below). All primary analyses will be based on intention to treat and will be conducted separately for people with T2DM and prediabetes. Primary analysis will use linear mixed models comparing mean outcome levels adjusted for initial baseline characteristics at 12 months. In addition, a process evaluation will assess the quality of the delivery of each aspect of the intervention, the extent to which each was enacted by participants and the impact of these factors on the outcomes of the intervention. Data include: 1) usage data from the mobile/web based platform 2) recorded audio interactions between coaches and participants 3) feedback from participants individually and as a part of focus groups at the end of the study period. A cost-effectiveness evaluation will take a health system perspective with intervention, healthcare, medication, and out-of-pocket patient costs assessed. Cost effectiveness will be assessed against RCT outcomes.
Main outcome measures
The primary outcome measure for the RCT is change in HbA1c at 12 months. Secondary outcomes are changes in weight, waist:hip ratio, blood pressure, patient activation and diabetes-specific behaviours and outcomes. All outcomes will be assessed at 4 and 12 months for the total study population and for Māori and Pacific specifically. The process evaluation will assess the uptake of the individual components of the programme and their association with positive outcomes, and feedback from participants. The economic evaluation will produce incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves calculated for outcomes showing significant between-group differences at 12-months. These may include ICERs per controlled patient, per unit reduction in BMI/WHR, and per quality-adjusted life-year.
University of Otago:
- Diana Sarfati, Professor, University of Otago, Wellington
- Melissa McLeod, Senior Research Fellow, University of Otago, Wellington
- Virginia Signal, Research Fellow, University of Otago, Wellington
- James Stanley, Biostatistician, University of Otago, Wellington
- Jeannine Stairmand, Research Fellow, University of Otago, Wellington
- Jeremy Krebs, Endocrinologist, Capital and Coast DHB, and Associate Professor, University of Otago, Wellington
- Tony Dowell, Professor of Primary Care, University of Otago, Wellington
- William Leung, Health economist, University of Otago, Wellington
- Cheryl Davies, Māori health researcher
- Rebecca Grainger, Physician and eHealth researcher, Capital and Coast DHB, and University of Otago, Wellington