Integrating Depression Care in Acute Coronary Syndromes Care in China

Not Applicable

Completed

• Conditions: Depression; Acute Coronary Syndromes
• Interventions: Other: Integrated care

• 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

Arm && Interventions

Group	Intervention	Description
Intervention Care (IC)	Integrated care	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.

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