基于移动设备的干预在接受冠状动脉旁路移植术的糖尿病患者中的血糖控制-一项随机对照试验的研究方案。

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

机构信息

Department of Cardiovascular Surgery, National Clinical Research Center of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.

出版信息

Trials. 2023 Sep 13;24(1):585. doi: 10.1186/s13063-023-07580-x.

DOI:10.1186/s13063-023-07580-x

PMID:37705074

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10498600/

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) at 6 months. Secondary outcomes include a change in the proportions of patients achieving HbA, 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.

摘要

背景

通过应用互联网和移动电话技术，可以为冠状动脉旁路移植术（CABG）后的糖尿病患者提供教育和经过培训的同伴支持。我们正在进行一项随机对照试验，以评估基于移动的辅导干预在改善 CABG 后糖尿病患者的危险因素控制和二级预防方面的疗效和可行性。

方法

使用基于小程序的干预措施改善冠状动脉旁路移植术后糖尿病患者的血糖控制以促进自我管理（GUIDE ME）研究是一项多中心、随机对照试验，在中国的 2 家医院进行，比较移动干预与标准治疗，随访 6 个月。干预措施是基于微信小程序的教育和提醒系统。干预组的参与者在 6 个月内接受了 180 个关于二级预防教育的视频（包括台词）以及标准治疗。采用行为改变技术，如提示识别障碍、激励技能和设定目标。GUIDE ME 研究的总样本量为 820 例患者即可。主要结局是 6 个月时血糖血红蛋白（HbA）的变化。次要结局包括达到 HbA、空腹血糖、收缩压、低密度脂蛋白胆固醇（LDL-C）和药物依从性的患者比例的变化。