Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 5, 2022
Date Accepted: Nov 18, 2022
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Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD)- a Clinical Non-randomised Pilot Trial in Brunei Darussalam: Study Protocol
ABSTRACT
Background:
The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide, and the estimated prevalence is 12.4% amongst the 20-75 years old group in Brunei Darussalam. Digital intervention has been shown to be cost-effective in the management of T2DM and provide a better accessibility of lifestyle intervention. A combination of digital intervention with support by professional management can enhance users with better self-efficacy than digital intervention alone.
Objective:
The study aims to determine the potential effectiveness and feasibility of the proposed 16-week digital intervention programme for T2DM self-management, and to guide the roll out of a mobile application (APP) as part of the population health solution for adults with T2DM in Brunei Darussalam. The primary outcome of this study is to measure the proportion of participants with HbA1c reduction of at least 0.6% from baseline; and the secondary outcomes include a change in 1) HbA1c, 2) body mass index, 3) lipid profile and 4) EQ-5D-5L.
Methods:
This single-arm, non-randomised pilot study includes 1) participant recruitment in an online [leverage on the national healthcare information and management system to select eligible individuals, national healthcare APP (BruHealth) and official social media platforms for outreach] and offline manner (in-person recruitment at health centres), 2) selection of 180 individuals with T2DM aged between 20 and 70 years who fulfill the study inclusion criteria with baseline data collection at offline health centres, followed by enrolment into a 16-week digital intervention programme which consists of online and offline support, 3) evaluation of relevant markers post-intervention (state markers being measured).
Results:
The study started in April 2022. It has received approval by the Medical and Health Research and Ethics Committee of the Brunei Ministry of Health (MHREC/MOH/2022/4(1)). This pilot study is still ongoing and preliminary results will be available by November 2022.
Conclusions:
The conclusions will be able to provide evidence to prove the effectiveness of the developed 16-week digital intervention programme for T2DM management, feasibility of the proposed model of care and as a guide to roll out an APP as a digital solution in Brunei Darussalam with the intention to optimise the quality of life for individuals with T2DM. Clinical Trial: ClinicalTrials.gov NCT05364476
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