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

Acute Coronary Syndrome Clinical Trial

— CHIPCHAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795505
• Other study ID #: CHIPCHAT
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1424
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stable Chronic Angina

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
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

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization	1 year
Secondary	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
Secondary	heart rates	standard protocol	1 year
Secondary	smoking cessation	self-reported	1 year
Secondary	drinking cessation	self-reported	1 year
Secondary	body mass index	standard protocol	1 year
Secondary	medications adherence	self-reported	1 year
Secondary	LDL	standard protocol	1 year
Secondary	HbA1c	standard protocol	1 year

External Links

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