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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
4,043
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.
The George Institute for Global Health, China
Haidian, Beijing Municipality, China
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
Time frame: 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
Time frame: Before patient discharge and after 12 months from discharge
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.
Time frame: 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
ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.
Time frame: At 6 and 12 months after discharge
Quality of life (EQ5D) at 6 and 12 months after discharge
Time frame: At 6 and 12 months after discharge
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