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I-CARE randomized clinical trial integrating depression and acute coronary syndrome care in low-resource hospitals in China: Design and rationale

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机构: [a]The George Institute for Global Health at Peking University Health Science Center(PUHSC), Beijing, China [b]Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA [c]Peking University Institute ofMental Health (Sixth Hospital), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Key Laborary of Mental Health, Ministry of Health (Peking University), Beijing, China [d]Beijing Anzhen Hospital, Capital Medical University, Beijing, China [e]The George Institute for Global Health, University of New SouthWales, Sydney, Australia [f]Peking University School of Public Health, Beijing, China [g]The Department of Biostatistics, Duke University, Durham, NC, USA [h]The George Institute for Global Health, India, New Delhi, India [i]The George Institute for Global Health, University of Oxford, Oxford, United Kingdom [j]The Department of Cardiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [k]Peking University Clinical Research Institute, Beijing, China
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摘要:
Depression and acute coronary syndromes (ACS) are both common public health challenges. Patients with ACS often develop depression, which in turn adversely affects prognosis. Low-cost, sustainable, and effective service models that integrate depression care into the management of ACS patients to reduce depression and improve ACS outcomes are critically needed. Integrating Depression Care in ACS patients in Low Resource Hospitals in China (I-CARE) is a multicenter, randomized controlled trial to evaluate the efficacy of an 11-month integrated care (IC) intervention compared to usual care (UC) in management of ACS patients. Four thousand inpatients will be recruited and then randomized in a 1:1 ratio to an IC intervention consisting of nurse-led risk factor management, group-based counseling supplemented by individual problem-solving therapy, and antidepressant medications as needed, or to UC. The primary outcomes are depression symptoms measured by the Patient Health Questionnaire-9 at 6 and 12 months. Secondary endpoints include anxiety measured by the Generalized Anxiety Disorder-7; quality of life measured by the EQ-5D at 6 and 12 months; and major adverse events including the combined end point of all-cause death, suicide attempts, nonfatal myocardial infarction, nonfatal stroke, and all-cause rehospitalization at yearly intervals for a median follow-up of 2 years. Analyses of the cost-effectiveness and cost-utility of IC also will be performed. I-CARE trial will be the largest study to test the effectiveness of an integrated care model on depression and cardiovascular outcomes among ACS patients in resource-limited clinical settings. (C) 2018 Elsevier Inc. All rights reserved.

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出版当年[2017]版:
大类 | 2 区 医学
小类 | 3 区 心脏和心血管系统
最新[2023]版:
大类 | 2 区 医学
小类 | 3 区 心脏和心血管系统
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出版当年[2016]版:
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子: 最新[2023版] 最新五年平均 出版当年[2016版] 出版当年五年平均 出版前一年[2015版] 出版后一年[2017版]

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第一作者机构: [a]The George Institute for Global Health at Peking University Health Science Center(PUHSC), Beijing, China
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通讯机构: [a]The George Institute for Global Health at Peking University Health Science Center(PUHSC), Beijing, China [k]Peking University Clinical Research Institute, Beijing, China [*1]Level 18, Horizon Tower B, No.6 Zhichun Rd, Haidian District, Beijing 100088, China.
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