Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"
Not Applicable
Completed
- Conditions
- Heart Failure
- Registration Number
- NCT03457623
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the effectiveness of a service package compared to conventional follow-up in people with heart failure. 6 months The outcome measure is the number of hospitalization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Groupe Hospitalier Mutualiste
🇫🇷Grenoble, France
CHU Grenoble-Alpes
🇫🇷Grenoble, France
Groupe Hospitalier Mutualiste🇫🇷Grenoble, France