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)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Ischemic Heart Disease; Stable Chronic Angina
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Control

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1424

Contacts and Locations

• Study Contact: Name: Boqun Shi, MD; Phone Number: +8615130119516; Email: shiboqun@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants are screened from several community hospitals and tertiary-A hospitals in Beijing

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention group; A tertiary A-level hospital WeChat-based intervention	Behavioral: Intervention; The subsequent visit was through WeChat-based online consultations. Follow-up, assessments and feedback were done at each visit. After follow-up, medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided.
Control group; Traditional community hospital intervention	Behavioral: Control; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements.	1 year
heart rates	standard protocol	1 year
smoking cessation	self-reported	1 year
drinking cessation	self-reported	1 year
body mass index	standard protocol	1 year
medications adherence	self-reported	1 year
LDL	standard protocol	1 year
HbA1c	standard protocol	1 year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Weihua Song, MD, Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
• Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
• Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.
• Shi B, Liu X, Dong Q, Yang Y, Cai Z, Wang H, Yin D, Wang H, Dou K, Song W. The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study. JMIR Mhealth Uhealth. 2021 Oct 27;9(10):e32548. doi: 10.2196/32548.

Helpful Links

• Number of monthly active WeChat users from 2nd quarter 2011 to 2nd quarter 2020(in millions)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Angina, Stable
• Other Study ID Numbers: CHIPCHAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No