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OpenTrials
Completed

NCT Number: NCT04795505

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

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.

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Key information

Conditions

Stable Chronic Angina Acute Coronary Syndrome Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Ischemic Heart Disease Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18-99 years
  • 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)
  • have sufficient Chinese language proficiency to reading, speaking and listening
  • live with at least one caregiver or guardian in the household
  • presence of stable hemodynamics without using vasopressor
  • able to individually consent
  • not participating in any other clinical trial

Exclusion criteria

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

Treatment and study plan

Intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. MACCE

    Time frame: 1 year

    acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization

Secondary outcomes

  1. blood pressure

    Time frame: 1 year

    BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements.

  2. heart rates

    Time frame: 1 year

    standard protocol

  3. smoking cessation

    Time frame: 1 year

    self-reported

  4. drinking cessation

    Time frame: 1 year

    self-reported

  5. body mass index

    Time frame: 1 year

    standard protocol

  6. medications adherence

    Time frame: 1 year

    self-reported

  7. LDL

    Time frame: 1 year

    standard protocol

  8. HbA1c

    Time frame: 1 year

    standard protocol

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Acronym: CHIPCHAT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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