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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by The George Institute for Global Health, China
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Peking University Sixth Hospital
Information provided by (Responsible Party):
The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT02195193
First received: July 15, 2014
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Acute Coronary Syndromes
Depression
Other: Integrated care model for ACS and depression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China

Resource links provided by NLM:


Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months [ Time Frame: Before patient discharge and after 6 months from discharge ] [ Designated as safety issue: No ]
  • Changes in mean PHQ-9 score from baseline to 12 months [ Time Frame: Before patient discharge and after 12 months from discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: At least 12 months after discharge ] [ Designated as safety issue: No ]
    MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.

  • Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months [ Time Frame: At 6 and 12 months after discharge ] [ Designated as safety issue: No ]
    ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.

  • Quality of life (EQ5D) at 6 and 12 months after discharge [ Time Frame: At 6 and 12 months after discharge ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence of Major Adverse Events (MACE) after discharge [ Time Frame: At 6 month and 12 month after patients discharged from hospital ] [ Designated as safety issue: No ]
    Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge

  • Proportion of patients with improved cardiovascular risk surrogates [ Time Frame: At 6 month and 12 month after discharge ] [ Designated as safety issue: No ]
    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

  • Proportion of patients with increased healthy life style [ Time Frame: At 6 and 12 months after discharge ] [ Designated as safety issue: No ]
    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

  • Proportion of patients with self-reported adherence to general medicine treatment [ Time Frame: At 6 and 12 months after discharge ] [ Designated as safety issue: No ]
  • The interactions between the intervention effect on the outcomes and the modifiers [ Time Frame: At 6 month or 12 month after discharge ] [ Designated as safety issue: No ]
    Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender

  • Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score [ Time Frame: Before patient discharge and at 6,12 months after discharge ] [ Designated as safety issue: No ]
    Subsample study. 800 patients from 4 hospitals.


Estimated Enrollment: 4000
Study Start Date: November 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 model for ACS and depression
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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195193

Contacts
Contact: Yangfeng Wu, MD +86-10-82800577 ext 600 ywu@georgeinstitute.org.cn

Locations
China, Beijing
The George Institute for Global Health, China Recruiting
Haidian, Beijing, China, 100088
Contact: Yangfeng Wu, MD    +86-10-82800577 ext 600    ywu@geogreinstitute.org.cn   
Sponsors and Collaborators
The George Institute for Global Health, China
National Institute of Mental Health (NIMH)
Peking University Sixth Hospital
Investigators
Principal Investigator: Yangfeng Wu, MD, PhD The Geogre Institute for Global Health, China
  More Information

Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT02195193     History of Changes
Other Study ID Numbers: I-CARE  R01MH100332 
Study First Received: July 15, 2014
Last Updated: August 17, 2016
Health Authority: China: The George Institute for Global Health, China

Keywords provided by The George Institute for Global Health, China:
Health Services Research
Acute Coronary Syndromes
Depression
Integrated care

Additional relevant MeSH terms:
Myocardial Ischemia
Syndrome
Depression
Depressive Disorder
Acute Coronary Syndrome
Disease
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 24, 2016