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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH100332 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Peking University Sixth Hospital | OTHER |
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The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (UC) | No Intervention | The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to "Usual Care" [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228 | |
| Intervention Care (IC) | Experimental | Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated care | Other | an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months | Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months | Before patient discharge and after 6 months from discharge |
| Changes in mean PHQ-9 score from baseline to 12 months | Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months | Before patient discharge and after 12 months from discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events (MACE) | MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease. | At least 12 months after discharge |
| Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Events (MACE) after discharge | Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge | At 6 month and 12 month after patients discharged from hospital |
| Proportion of patients with improved cardiovascular risk surrogates |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yangfeng Wu, MD, PhD | The Geogre Institute for Global Health, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Institute for Global Health, China | Haidian | Beijing Municipality | 100088 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39040037 | Derived | Wu Y, Yu X, Zhu Y, Shi C, Li X, Jiang R, Niu S, Gao P, Li S, Yan L, Maulik PK, Guo G, Patel A, Gao R, Blumenthal JA. Integrating depression and acute coronary syndrome care in low resource hospitals in China: the I-CARE randomised clinical trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101126. doi: 10.1016/j.lanwpc.2024.101126. eCollection 2024 Jul. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019033 | Delivery of Health Care, Integrated |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker. |
| At 6 and 12 months after discharge |
| Quality of life (EQ5D) at 6 and 12 months after discharge | At 6 and 12 months after discharge |
Improved cardiovascular risk surrogates include blood pressure < 140/90 mmHg, heart rate < 70 beats/m, serum Low Density Lipoprotein-cholesterol < 100 mg/dL and blood sugar < 7.0 mmol/L |
| At 6 month and 12 month after discharge |
| Proportion of patients with increased healthy life style | Health life style includes physical activity >= 3 times/wk and more than 30 min. each time; no smoking, no alcohol use, and Body Mass Index (BMI) < 24 Kg/m2 | At 6 and 12 months after discharge |
| Proportion of patients with self-reported adherence to general medicine treatment | The Morisky scale has been used to measure patients' self-reported adherence | At 6 and 12 months after discharge |
| The interactions between the intervention effect on the outcomes and the modifiers | Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender | At 6 month or 12 month after discharge |
| Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score | Subsample study. 800 patients from 4 hospitals. | Before patient discharge and at 6,12 months after discharge |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |