Integrating Depression Care in Acute Coronary Syndromes Care in China

Depression Clinical Trial

— I-Care  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195193
• Other study ID #: I-CARE
• Secondary ID: R01MH100332
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4043
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Depression
• Depressive Disorder
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	The George Institute for Global Health, China	Haidian	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	National Institute of Mental Health (NIMH), Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Quality of life (EQ5D) at 6 and 12 months after discharge		At 6 and 12 months after discharge