The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.
Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease. Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up. Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up. Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker. 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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want.
Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China
Medication adherence
Compliance and administration of cardiovascular protective drugs
Time frame: 1 year
Blood Pressure
BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements
Time frame: 1 year
Body Mass Index
standard protocol
Time frame: 1 year
LDL Cholesterol
standard protocol
Time frame: 1 year
HbA1c
standard protocol
Time frame: 1 year
Smoking
self-reported
Time frame: 1 year
Drinking
self-reported
Time frame: 1 year
Aspirin
self-reported
Time frame: 1 year
P2Y12 receptor antagonist
self-reported
Time frame: 1 year
Statin
self-reported
Time frame: 1 year
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ACEI/ARB
self-reported
Time frame: 1 year
Beta-blocker
self-reported
Time frame: 1 year
MACCE
acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization
Time frame: 1 year