The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 主要终点
- Psychosocial status (depression, anxiety)
研究概览
简要总结
Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
排除标准
- •End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
- •A serious life-threatening illness with a life-expectancy of <6 months Within the past 3 months
- •Cognitive dysfunction
- •Substance abuse or psychotic disorder
- •Managed by visiting nursing
- •Long distance between patients' home and hospital
结局指标
主要结局
Psychosocial status (depression, anxiety)
时间窗: up to 12 months
次要结局
- Death(up to 12 months)
- Readmission due to heart failure(up to 12 months)
- Hospital admission(up to 12 months)
- Quality of life(up to 12 months)
- Physical activity(up to 12 months)