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Abstract
Introduction Pre-diabetes indicates an elevated risk of developing type-2 diabetes and presents a window for preventive actions. The Pre-diabetes Intervention, Management and Evaluation (PRIME) programme is a community pharmacy-based pre-diabetes management programme that uses a mobile application for self-monitoring and pre-diabetes education, aiming to promote lifestyle changes among participants with pre-diabetes.
Methods and analysis This is a protocol for a cluster randomised controlled trial that aims to evaluate the impact of the PRIME programme on participants’ clinical outcomes and explore participants’ and pharmacists’ views towards its implementation. This protocol describes the development of the PRIME programme and mobile app, its feasibility and implementation in community pharmacy settings. 16 pharmacies from two states in Malaysia will be randomised to the intervention arm or standard care. The study will include overweight or obese adults with pre-diabetes. During each follow-up visit at the pharmacy, intervention participants will receive in-depth counselling from pharmacists after reviewing their self-monitoring data recorded in the PRIME app. They will also receive pre-diabetes education through the app and join a peer support chatgroup. The primary clinical outcome includes changes in body weight at 6 months, while the secondary clinical outcomes include changes in blood glucose profile, lipid profile, blood pressure and adiposity measures. The sustainability of the PRIME programme will be accessed using a follow-up questionnaire, while participants’ engagement with the intervention will be evaluated using attendance rate and the app data. Focus group discussions and one-to-one interviews will be conducted for process evaluation. This study will inform the impact of community pharmacists-led digital health intervention in pre-diabetes management.
Ethics and dissemination This study has been registered with clinicaltrials.gov (NCT04832984) and approved by the Monash University Human Research Ethics Committee (Project ID: 27512).
Trial registration number clinicaltrials.gov (NCT04832984).
- Clinical trials
- Diabetes & Endocrinology
- Epidemiology
- Primary Prevention
- eHealth
- Behaviour
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X @CarmenTeoh, @markcheongwl
Contributors KWT: conceptualisation, methodology, investigation, ethical approval, writing—original draft, writing—review and editing, visualisation and project administration, resources. SWHL: conceptualisation, methodology, writing—review and editing, resources, supervision. CMN: conceptualisation, writing—review and editing, supervision. CWC: conceptualisation, funding acquisition, writing—review and editing, supervision. YLN: conceptualisation, writing—review and editing, resources. JSB: methodology, writing—reviews and edits, supervision. WLC: methodology, writing—review and editing. All authors read and approved the final manuscript. The guarantor of the study is SWHL; accepts full responsibility for the finished work and/or the conduct of the study, has access to the data and controls the decision to publish.
Funding This work was supported by the Monash University Malaysia Network for Equity through Digital Health (NEED) Grant (Project code: I-M010-MTC-000007). Funding for this trial covers the purchase of equipment and consumables needed in the study, hiring of a research assistant and fieldwork travel expenses only. The design, collection, management, analysis, data interpretation, and reporting of this protocol are conducted independently from the funding body.
Competing interests None declared.
Patient and public involvement Patients and/or the public will be involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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