Clinical trial NCT02195193: Integrating Depression Care in Acute Coronary Syndromes Care in China
Official title: Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Depression
Keywords: Health Services Research
Acute Coronary Syndromes
Depression
Integrated care
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Peking University Sixth Hospital
First posted: 2014-07-21
Enrollment: 4043
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
timeFrame: Before patient discharge and after 6 months from discharge
measure: Changes in mean PHQ-9 score from baseline to 12 months
timeFrame: Before patient discharge and after 12 months from discharge
Secondary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events (MACE)
timeFrame: At least 12 months after discharge
measure: Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months
timeFrame: At 6 and 12 months after discharge
measure: Quality of life (EQ5D) at 6 and 12 months after discharge
timeFrame: At 6 and 12 months after discharge
Other outcomes:
measure: Incidence of Major Adverse Events (MACE) after discharge
timeFrame: At 6 month and 12 month after patients discharged from hospital
measure: Proportion of patients with improved cardiovascular risk surrogates
timeFrame: At 6 month and 12 month after discharge
measure: Proportion of patients with increased healthy life style
timeFrame: At 6 and 12 months after discharge
measure: Proportion of patients with self-reported adherence to general medicine treatment
timeFrame: At 6 and 12 months after discharge
measure: The interactions between the intervention effect on the outcomes and the modifiers
timeFrame: At 6 month or 12 month after discharge
measure: Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score
timeFrame: Before patient discharge and at 6,12 months after discharge
Locations:
city: Haidian
country: China
facility: The George Institute for Global Health, China
state: Beijing
Study officials:
affiliation: The Geogre Institute for Global Health, China
name: Yangfeng Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: