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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Remote intervention |
|
| Control group | Active Comparator | Routine outpatient follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Compliance and administration of cardiovascular protective drugs | 1 year |
| 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 |
| Body Mass Index | standard protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weihua Song, MD | Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30998400 | Background | 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. | |
| 32745732 |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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|
| Routine outpatient follow-up | Behavioral | Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. |
|
| 1 year |
| LDL Cholesterol | standard protocol | 1 year |
| HbA1c | standard protocol | 1 year |
| Smoking | self-reported | 1 year |
| Drinking | self-reported | 1 year |
| Aspirin | self-reported | 1 year |
| P2Y12 receptor antagonist | self-reported | 1 year |
| Statin | self-reported | 1 year |
| ACEI/ARB | self-reported | 1 year |
| Beta-blocker | self-reported | 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 | 1 year |
| Background |
| 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. |
| 32858284 | Background | 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. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |