The Study Design of a Mobile Health (mHealth) Technology Associated Improvement of Drug Adherence in Patients With Acute Myocardial Infarction and Protocol for the Randomized, Controlled Trial（RESCIND-3)
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of discontinuation of drug
研究概览
简要总结
The RESCIND-3 study is a multicenter, double-blind, randomized controlled trial. It will be conducted in the departments of cardiology in 5 hospitals. Guangdong General Hospital ethics review board approved the study's design. 400 patients with AMI on admission will be continuously enrolled and randomly allocated to either the control or intervention group. The intervention group will receive internet-based counseling, individual drug reminders, recommendations for healthy lifestyles, cardiovascular education about AMI, and follow-up reminders four times a week, while the control group will only receive cardiology knowledge and follow-up reminders four times a week. Mobile health tools (WeChat applet) were developed through cooperation with a technology company to establish appropriate It will be blinding for investigators but all participants will be aware of whether their intervention is the 'experimental' treatment. Trained research nurses will conduct the follow up in the 4th, 8th, 12th months by telephone or face-to-face visit. All the adverse events will be collected through a self-reported section in the mobile health tools. The study will evaluate the acceptability, utility of the intervention based on Internet consulting management.
详细描述
Background：Antithrombotic drugs, β-blockers, statins and angiotensin converting enzyme inhibitor (ACEI)/angiotensin II receptor blockers (ARB) are recommended for patients with acute myocardial infarction(AMI). However, discontinuation of the drugs was associated with higher mortality. Few studies focused on the improvement of drug compliance through mHealth tools.
Objective：To investigate whether internet-based counseling could improve drug(Antithrombotic drugs, β-blockers, statins an ACEI/ARB) compliance following percutaneous coronary intervention(PCI) among patients with AMI within 1year's follow-up.
Study design：The study is a multicenter, randomized, prospective, double-blinded study. A total of 400 AMI patients following PCI will be randomized to intervention group or control group in addition to usual post-MI care. The intervention group will receive internet-based counseling, personalized reminders(drug information, healthy lifestyles advise) and educational message (cardiovascular knowledge and follow-up reminders) four times a week. It will be only usual messages (cardiovascular knowledge and follow-up reminders) supported four times a week in the control group. The primary endpoint is the discontinuation rate of coronary heart disease secondary prevention drugs (antiplatelet, ACEI/ARB, beta-blockers, and statins). The second endpoints include drug adherence scores assessed by the proportion of days covered(PDC) and major adverse cardiovascular events. Both groups will be followed up within 1year after PCI.
Summary：The multicentre randomized trial(RESCIND-3) will provide new evidence of the effectiveness of mHealth tools on improving 12-month drug compliance following PCI among patients with AMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research personnel, investigators, study coordinators and research assistants conducting the assessments and statisticians will not be informed of the allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Diagnosed with acute myocardial infarction
- •Taking four kinds of cardioprotective medications(antiplatelet, ACEI/ARB, beta-blockers, and statins)
- •Wechat and smartphone users
- •Provide written informed consent
排除标准
- •Pregnancy
- •Malignant tumor or end-stage disease with a life expectancy of <1 year
- •Unable to use mobile phone network applet
- •Refuse to sign the informed consent
研究组 & 干预措施
Intervention Group
The intervention group will receive a complete social medial tool (web-based application ) installed on mobile phones including general education about coronary disease、personalized reminders and internet-based counseling. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone.
干预措施: Usual Text Messages (Behavioral)
Intervention Group
The intervention group will receive a complete social medial tool (web-based application ) installed on mobile phones including general education about coronary disease、personalized reminders and internet-based counseling. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone.
干预措施: Personalized reminders (Behavioral)
Intervention Group
The intervention group will receive a complete social medial tool (web-based application ) installed on mobile phones including general education about coronary disease、personalized reminders and internet-based counseling. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone.
干预措施: Internet-based counselling (Behavioral)
Control Group
The control group will receive a simplified tool including only the education message. The methodology will ensure that potential confounders by differences in nonspecific support and attention could be adjusted. Regular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behavior. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone.
干预措施: Usual Text Messages (Behavioral)
结局指标
主要结局
Rate of discontinuation of drug
时间窗: 1 year
The discontinuation rate of each 4 kinds of coronary heart disease secondary prevention drug (antiplatelet drugs, ACEI/ARB, beta-blockers, and statins) without any professional permission. The continuous withdrawal time will be divided into three groups: ≤7 days, 8-30 days, more than 30 days.
次要结局
- Medication discontinuance(1 year)
- Acute myocardial infarction(1 year)
- Good drug compliance(1 year)
- Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR)(1 year)
研究者
Liu yong
Director
Guangdong Provincial People's Hospital