Coronary Artery Disease Clinical Trial
Official title:
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)
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.
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.
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