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Completed

NCT Number: NCT02195193

Integrating Depression Care in Acute Coronary Syndromes Care 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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Institute for Global Health, China

Haidian, Beijing Municipality, 100088, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Integrated care

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.

Primary outcomes

  1. 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

    Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months

  2. Changes in mean PHQ-9 score from baseline to 12 months

    Time frame: Before patient discharge and after 12 months from discharge

    Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months

Secondary outcomes

  1. Incidence of Major Adverse Cardiovascular Events (MACE)

    Time frame: At least 12 months after discharge

    MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.

  2. 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

    ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.

  3. Quality of life (EQ5D) at 6 and 12 months after discharge

    Time frame: At 6 and 12 months after discharge

Other outcomes

  1. Incidence of Major Adverse Events (MACE) after discharge

    Time frame: At 6 month and 12 month after patients discharged from hospital

    Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge

  2. Proportion of patients with improved cardiovascular risk surrogates

    Time frame: At 6 month and 12 month after discharge

    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

  3. Proportion of patients with increased healthy life style

    Time frame: At 6 and 12 months after discharge

    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

  4. Proportion of patients with self-reported adherence to general medicine treatment

    Time frame: At 6 and 12 months after discharge

    The Morisky scale has been used to measure patients' self-reported adherence

  5. The interactions between the intervention effect on the outcomes and the modifiers

    Time frame: At 6 month or 12 month after discharge

    Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender

  6. 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

    Subsample study. 800 patients from 4 hospitals.

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Peking University Sixth Hospital

Registry information

Official study title

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

Acronym: I-Care

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2014
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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