NCT02195193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,043

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

3.3 years

First QC Date

July 15, 2014

Last Update Submit

May 17, 2018

Conditions

Acute Coronary SyndromesDepression

Keywords

Health Services ResearchAcute Coronary SyndromesDepressionIntegrated care

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Incidence of Major Adverse Cardiovascular Events (MACE)

    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

    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 Outcomes (6)

  • Incidence of Major Adverse Events (MACE) after discharge

    At 6 month and 12 month after patients discharged from hospital

  • Proportion of patients with improved cardiovascular risk surrogates

    At 6 month and 12 month after discharge

  • Proportion of patients with increased healthy life style

    At 6 and 12 months after discharge

  • +3 more other outcomes

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

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

Intervention Care (IC)

EXPERIMENTAL

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

Interventions

Integrated careOTHER

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.

Intervention Care (IC)

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Institute for Global Health, China

Haidian, Beijing Municipality, 100088, China

Location

Related Publications (1)

  • Wu Y, Yu X, Zhu Y, Shi C, Li X, Jiang R, Niu S, Gao P, Li S, Yan L, Maulik PK, Guo G, Patel A, Gao R, Blumenthal JA. Integrating depression and acute coronary syndrome care in low resource hospitals in China: the I-CARE randomised clinical trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101126. doi: 10.1016/j.lanwpc.2024.101126. eCollection 2024 Jul.

    PMID: 39040037DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeDepression

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Yangfeng Wu, MD, PhD

    The Geogre Institute for Global Health, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 21, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

CN(1)