Integrating Depression Care in Acute Coronary Syndromes Care in China

Not Applicable

Completed

• Conditions: Depression; Acute Coronary Syndromes

• Registration Number: NCT02195193
• Lead Sponsor: The George Institute for Global Health, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Study Start: 2014-11
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4043

Inclusion Criteria

• Age 20 to 79 years old
• Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)
• ACS is stable (as judged by the treating cardiologist/internist)
• Signed patient informed consent

Exclusion Criteria

• Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer)
• Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline)
• Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)
• Non-permanent local residents or permanent residents planning to move out within 12 months
• Pregnant or breast-feeding or planning pregnancy within 12 months
• Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3)
• Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in mean PHQ-9 score from baseline to 12 months	Before patient discharge and after 12 months from discharge	Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 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 Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiovascular Events (MACE)	At least 12 months after discharge	MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.
Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months	At 6 and 12 months after discharge	ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.
Quality of life (EQ5D) at 6 and 12 months after discharge	At 6 and 12 months after discharge

Trial Locations

Locations (1)

The George Institute for Global Health, China; 🇨🇳 Haidian, Beijing, China

The George Institute for Global Health, China

🇨🇳Haidian, Beijing, China