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

Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China

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 Overview

• Status: Completed
• Conditions: Depression; Acute Coronary Syndromes
• Intervention / Treatment: Other: Integrated care

• Study Type: Interventional
• Enrollment (Actual): 4043
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Haidian, Beijing, China, 100088
      • The George Institute for Global Health, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Before patient discharge and after 12 months from discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 6 and 12 months after discharge
Quality of life (EQ5D) at 6 and 12 months after discharge		At 6 and 12 months after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Major Adverse Events (MACE) after discharge	Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge	At 6 month and 12 month after patients discharged from hospital
Proportion of patients with improved cardiovascular risk surrogates	Improved cardiovascular risk surrogates include blood pressure < 140/90 mmHg, heart rate < 70 beats/m, serum Low Density Lipoprotein-cholesterol < 100 mg/dL and blood sugar < 7.0 mmol/L	At 6 month and 12 month after discharge
Proportion of patients with increased healthy life style	Health life style includes physical activity >= 3 times/wk and more than 30 min. each time; no smoking, no alcohol use, and Body Mass Index (BMI) < 24 Kg/m2	At 6 and 12 months after discharge
Proportion of patients with self-reported adherence to general medicine treatment	The Morisky scale has been used to measure patients' self-reported adherence	At 6 and 12 months after discharge
The interactions between the intervention effect on the outcomes and the modifiers	Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender	At 6 month or 12 month after discharge
Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score	Subsample study. 800 patients from 4 hospitals.	Before patient discharge and at 6,12 months after discharge

Collaborators and Investigators

• Sponsor: The George Institute for Global Health, China
• Collaborators: National Institute of Mental Health (NIMH); Peking University Sixth Hospital
• Investigators: Principal Investigator: Yangfeng Wu, MD, PhD, The Geogre Institute for Global Health, China

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Integrated care; Health Services Research; Acute Coronary Syndromes
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Disease; Depression; Depressive Disorder; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: I-CARE; R01MH100332 (U.S. NIH Grant/Contract)