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)
- Conditions
- Coronary Artery Disease
- Interventions
- Behavioral: Usual Text MessagesBehavioral: Personalized remindersBehavioral: Internet-based counselling
- Registration Number
- NCT04119726
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Internet-based counselling 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. Intervention Group Usual Text Messages 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. Intervention Group Personalized reminders 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. Control Group Usual Text Messages 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.
- Primary Outcome Measures
Name Time Method Rate of discontinuation of drug 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.
- Secondary Outcome Measures
Name Time Method Medication discontinuance 1 year Stop taking any one of antiplatelet drugs, β blockers, statins and ACEI/ARB without doctor's advice within one year of the onset of AMI.
Acute myocardial infarction 1 year Clinical evidence of acute myocardial injury(typical rise and fall of biochemical markers of myocardial necrosis to greater than twice the ULN or if markers were already elevated, further elevation of a marker to \>50% of a previous value that was decreasing and \>2× ULN, with ≥ 1 of the following) and myocardial ischemia, including: Myocardial ischemia; New ischemic ECG changes; Pathological Q wave appears; Imaging evidence and ischemic aetiology of new myocardium loss or abnormal local ventricular wall movement; Coronary thrombosis is determined by angiography or autopsy.
Good drug compliance 1 year It will be measured by the proportion of days covered (PDC) during one year following hospital discharge. Patients are classified as good compliance (PDC \>80%) or no-good compliance (\<80%) separately to each of the 4 preventive therapies.
Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR) 1 year All-cause mortality, defined as any death recorded between the date of the interview and the end of data linkage on 31 October 2016. Rehospitalization, stroke, target vascular revascularization (TVR). TVR is defined as any revascularization procedure (PCI or CABG) involving the vessel treated during the index PCI procedure for STEMI.
Trial Locations
- Locations (1)
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China