Clinical trial NCT04119726: 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)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Mobile health
Acute myocardial infarction
Cardioprotective medications
Randomized Controlled Trial
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Maoming People's Hospital
name: Dongguan People's Hospital
name: First People's Hospital, Shunde China
name: Guangzhou Panyu Central Hospital
First posted: 2019-10-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 appropriately. 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of discontinuation of drug
timeFrame: 1 year
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: 1 year
measure: Medication discontinuance
timeFrame: 1 year
measure: Good drug compliance
timeFrame: 1 year
measure: Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yong Liu, MD
role: STUDY_CHAIR
References: