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)
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedOctober 10, 2019
October 1, 2019
1.4 years
October 7, 2019
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of discontinuation of drug
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.
1 year
Secondary Outcomes (4)
Acute myocardial infarction
1 year
Medication discontinuance
1 year
Good drug compliance
1 year
Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR)
1 year
Study Arms (2)
Control Group
OTHERThe 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.
Intervention Group
EXPERIMENTALThe 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.
Interventions
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 behaviour.
Personal information, life behavior and risk factors will be registered when patients are enrolled. According to the baseline information, personalized knowledge will be sent to patients in the intervention group. Besides, patients will receive drug information and regular medication adherence reminders daily according to patients' baseline prescription drugs and modifications.
The internet-based counselling is the key module of social media in the intervention group. The consultation content mainly includes the feedback of coronary heart disease secondary prevention drug compliance, the feedback of risk factor level control, the feedback of life and behaviour habits, the feedback of adverse events, the feedback of health education knowledge improvement, the reminders of data upload, behaviour change, and health education learning. When the patient has questions or discomfort during the medication, they can consult the applet and the applet will perform internet-based answers on the large database built by cardiologists. Meanwhile, social media will upload the question of consultation and report to the doctor according to individual differences in disease. If the patient is not satisfied with the auto-response, the patient can further consult his doctor and the doctor's response will be collected to improve the auto-response database
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Provincial People's Hospitallead
- Maoming People's Hospitalcollaborator
- Dongguan People's Hospitalcollaborator
- First People's Hospital, Shunde Chinacollaborator
- Guangzhou Panyu Central Hospitalcollaborator
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yong Liu, MD
Guangdong Cardiovascular Institute,Guangdong General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Research personnel, investigators, study coordinators and research assistants conducting the assessments and statisticians will not be informed of the allocation.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 8, 2019
Study Start
January 1, 2019
Primary Completion
June 1, 2020
Study Completion
July 1, 2020
Last Updated
October 10, 2019
Record last verified: 2019-10