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)

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.

Conditions

• Coronary Artery Disease

Interventions

BEHAVIORAL

Usual Text Messages

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.

BEHAVIORAL

Personalized reminders

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.

BEHAVIORAL

Internet-based counselling

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

Sponsors & Collaborators

• Maoming People's Hospital

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• First People's Hospital, Shunde China

  collaborator OTHER

• Guangzhou Panyu Central Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Principal Investigators

• Yong Liu, MD · Guangdong Cardiovascular Institute,Guangdong General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2020-06-30

Completion

2020-07-31

Countries

• China

Study Locations