Integrating Depression Care in Acute Coronary Syndromes Care in China (I-Care)
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|ClinicalTrials.gov Identifier: NCT02195193|
Recruitment Status : Recruiting
First Posted : July 21, 2014
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment|
|Acute Coronary Syndromes Depression||Other: Integrated care model for ACS and depression|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
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.
- 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 PHQ-9 score from baseline to 12 months [ Time Frame: Before patient discharge and after 12 months from discharge ]
- 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.
- 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.
- Quality of life (EQ5D) at 6 and 12 months after discharge [ Time Frame: At 6 and 12 months after discharge ]
- 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
- 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
- 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
- Proportion of patients with self-reported adherence to general medicine treatment [ Time Frame: At 6 and 12 months after discharge ]
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195193
|Contact: Yangfeng Wu, MD||+86-10-82800577 ext email@example.com|
|The George Institute for Global Health, China||Recruiting|
|Haidian, Beijing, China, 100088|
|Contact: Yangfeng Wu, MD +86-10-82800577 ext 600 firstname.lastname@example.org|
|Principal Investigator:||Yangfeng Wu, MD, PhD||The Geogre Institute for Global Health, China|