Glycaemic control using mobile-based intervention in patients with diabetes undergoing coronary artery bypass-study protocol for a randomized controlled trial

在接受冠状动脉旁路移植术的糖尿病患者中,采用移动端干预控制血糖——一项随机对照试验的研究方案

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Abstract

BACKGROUND: Applying technology through the use of the Internet and mobile phones can help provide education and trained peer support for patients with diabetes after coronary artery bypass (CABG). We are conducting a randomized controlled trial to evaluate the efficacy and feasibility of mobile-based coaching intervention in improving risk-factor control and secondary prevention in patients with diabetes after CABG. METHODS: The glycaemic control using miniprogram-based intervention in patients with diabetes undergoing coronary artery bypass to promote self-management (GUIDE ME) study is a multi-centre, randomized controlled trial of mobile intervention versus standard treatment with 6 months follow-up conducted in 2 hospitals in China. The interventions are education and a reminder system based on the WeChat mini-program. Participants in the intervention groups receive 180 videos (including lines) about secondary prevention education for 6 months as well as the standard treatment. Behavioural change techniques, such as prompting barrier identification, motivational skills, and goal setting, are employed. A total sample size of 820 patients would be adequate for the GUIDE ME study. The primary outcome is the change of glycaemic haemoglobin (HbA(1c)) at 6 months. Secondary outcomes include a change in the proportions of patients achieving HbA(1c), fasting blood glucose, systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and medication adherence. DISCUSSION: This trial is the first to investigate the efficacy of mobile phone WeChat-based video coaching and medication reminder mini-program system to improve self-management in patients with diabetes and coronary heart disease (CHD) after CABG and has the potential to be applied in resource-limited settings across diverse populations. If successful, such mobile intervention could be used and scaled up to improve care for this high-risk group of patients. TRIAL REGISTRATION: ClinicalTrials, NCT04192409 . Registered on December 10, 2019.

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