Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up (CHIPCHAT)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Stable Chronic Angina; Ischemic Heart Disease; Acute Coronary Syndrome

Treatments: Behavioral: Intervention; Behavioral: Control

Study type: Observational

Funder types: Other

Identifiers

NCT04795505

CHIPCHAT

Details and patient eligibility

About

The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Full description

Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.

Study design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.

Study intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.

Outcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.

Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Enrollment: 1,424 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged between 18-99 years
2. diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
3. have sufficient Chinese language proficiency to reading, speaking and listening
4. live with at least one caregiver or guardian in the household
5. presence of stable hemodynamics without using vasopressor
6. able to individually consent
7. not participating in any other clinical trial

Exclusion criteria

1. unable to provide informed consent
2. unable to be involved in clinical follow up and treatment
3. suffered comorbidity with a life expectancy of less than 1 year
4. have contra-indication to cardiac rehabilitation
5. acute coronary syndrome

Trial design

1,424 participants in 2 patient groups

Intervention group

Description:

A tertiary A-level hospital WeChat-based intervention

Treatment:

Behavioral: Intervention

Control group

Description:

Traditional community hospital intervention

Treatment:

Behavioral: Control