Implementing a Scalable, personalised, behaviour Change digitAL hEalth programme in primary care for type 2 diabetes treatment: the SCALE cluster-randomised study protocol

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INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a fast-growing chronic disease, with at least 1.3 million people diagnosed in Australia. In the Western Sydney Local Health District (WSLHD), an estimated 13.1% of all adults have T2DM. The condition significantly contributes to cardiovascular, heart and kidney diseases and causes a large disease burden. Lifestyle modifications, such as improved nutrition, increased physical activity and stress reduction, are recommended as first-line treatments for T2DM management. However, the current primary care system cannot meet the growing demands for diabetes care, necessitating the development of innovative, scalable, cost-effective solutions. Digital health technologies present a promising approach for promoting self-management in individuals with T2DM. METHODS AND ANALYSIS: This cluster-randomised controlled trial aims to evaluate the feasibility and effectiveness of Gro-AUS, a localised version of the Gro Health app in Australia, to support T2DM management in Australian primary care settings. The trial will be conducted across multiple general practice clinics within the WSLHD, an area with a high prevalence of T2DM and significant cultural diversity in patient populations. Participants will be randomly assigned by clinic to either the intervention group (digital health programme) or control group (standard care). Primary outcomes include improvements in glycaemic control, cardiovascular risk factors and diabetes remission, with secondary outcomes such as weight loss, physical activity and mental well-being. Data will be collected using electronic and paper methods, with secure storage and de-identification ensuring participant privacy. The study's mixed-method approach ensures inclusivity for patients with varying levels of digital literacy. Data will be securely stored, de-identified and used to assess the effectiveness of the intervention. Findings are expected to inform future models of diabetes care in Australia, providing evidence for the scalability of digital health technologies in chronic disease management. STRENGTHS AND LIMITATIONS: This trial is by nature unblinded. The recruitment style for a stepped-wedge trial may also bias participant engagement. However, it has direct implications for clinical practice as an effectiveness implementation trial. The design also allows for a much larger sample and more statistical power to examine outcomes. ETHICS AND DISSEMINATION: This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. Ethical approval has been granted by the WSLHD Human Research Ethics Committee prior to data collection. Results will be disseminated through publication in a peer-reviewed medical journal and shared via the Agency for Clinical Innovation, the Primary Care Health Network and through community engagement initiatives. TRIAL REGISTRATION: ANZCTR388639.

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