Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,043
- 试验地点
- 1
- 主要终点
- Changes in mean PHQ-9 score from baseline to 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
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.
干预措施: Integrated care (Other)
结局指标
主要结局
Changes in mean PHQ-9 score from baseline to 12 months
时间窗: Before patient discharge and after 12 months from discharge
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
时间窗: Before patient discharge and after 6 months from discharge
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
次要结局
- 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)