Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04795505
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIPCHAT
Brief 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.
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: