NCT03457623已完成不适用
Medico-economic Evaluation of a "IsereADOM" Package of Services Versus Conventional Health and Social Monitoring, in the Care of a Population of People With Heart Failure in Isère.
University Hospital, Grenoble4 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- the effectiveness of a service package compared to conventional follow-up in people with heart failure.
研究概览
简要总结
The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure.
There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with heart failure confirmed by a cardiologist ;
- •Patient with functional NYHA II, III, IV staining ;
- •Patient domiciled in the department of Isère ;
- •Patient who can be followed regularly for 6 months ;
- •Patient who can benefit from RESIC-type health education ;
- •Presence of a caregiver referent of proximity (family or other) according to appreciation of the investigating doctor in case of cognitive disorders ;
- •Patient affiliated with social security or beneficiary of such a scheme ;
- •Patient able to read, write and understand French ;
- •Patient having signed informed consent to participate.
排除标准
- •Patient with peritoneal dialysis or haemofiltration ;
- •Patient with severe co-morbidity with poor short-term prognosis: mortality < 6 months ;
- •Patient with future surgical etiologic treatment: prosthetic valve, revascularization procedure, TAVI or MITRACLIP ;
- •Patient residing in a nursing home or institution for dependent person ;
- •Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).
结局指标
主要结局
the effectiveness of a service package compared to conventional follow-up in people with heart failure.
时间窗: 6 months
The outcome measure is the number of hospitalization
次要结局
未报告次要终点
研究者
研究点 (4)
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