Integrating Depression Care in Acute Coronary Syndromes Care in China (I-Care)

The George Institute for Global Health, China

Status: Completed

Conditions: Acute Coronary Syndromes; Depression

Treatments: Other: Integrated care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02195193

I-CARE

R01MH100332 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 4,043 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,043 participants in 2 patient groups

Usual Care (UC)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Integrated care