Integrating Depression Care in Acute Coronary Syndromes Care in China

NCT ID: NCT02195193

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4043 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-02-28

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.

Conditions

Acute Coronary Syndromes; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual Care (UC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Care (IC)

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.

Group Type: EXPERIMENTAL

Integrated care

Intervention Type: 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.

Interventions

Integrated care

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Peking University Sixth Hospital

OTHER

Sponsor Role: collaborator

The George Institute for Global Health, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yangfeng Wu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Geogre Institute for Global Health, China

Locations

The George Institute for Global Health, China

Haidian, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39040037 (View on PubMed)

Other Identifiers

R01MH100332

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I-CARE

Identifier Type: -

Identifier Source: org_study_id