Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India
Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India
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DOI：
10.1136/bmjopen-2016-014851
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发表时间：
2017-08-01
期刊：
影响因子：
2.9
通讯作者：
Prabhakaran, Dorairaj
中科院分区：
文献类型：
--
作者：
Jha, Dilip;Gupta, Priti;Prabhakaran, Dorairaj
简介 心血管疾病 (CVD) 和糖尿病负担的增加是印度卫生系统面临的重大挑战。移动电话技术 (mHealth) 等创新方法用于电子决策支持，为高血压、糖尿病和共病抑郁症提供循证综合护理，有可能改变初级医疗保健系统。方法和分析 mWellcare 试验是一项多中心、整群随机对照试验，评估移动医疗系统和护士管理护理对农村高血压和糖尿病患者的临床和成本效益 印度。 mWellcare 系统是一款基于 Android 的移动应用程序，旨在生成基于算法的临床管理提示，用于治疗高血压和糖尿病，还能够存储健康记录、发送跟踪和坚持用药的警报和提醒。我们从 40 个社区健康中心 (CHC) 总共招募了 3702 名参与者，其中干预和控制（强化护理）组中每个 CHC 的参与者均≥ 90 人。主要结果是两个治疗组之间收缩压和糖化血红蛋白 (HbA1c) 的平均变化（从基线到 1 年）的差异。次要结果是两个治疗组之间从基线到 1 年的空腹血糖、总胆固醇、预测 10 年 CVD 风险、抑郁、吸烟行为、体重指数和饮酒的平均变化以及成本效益的差异。 伦理与传播 该研究已获得印度公共卫生基金会和伦敦卫生与热带医学学院伦理委员会的批准。研究结果将通过同行评审出版物、会议演示和其他机制广泛传播。
Introduction Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysis mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with >= 90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.