NCT03457623CompletedNot Applicable
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 sites in 1 country66 target enrollmentStarted: November 20, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 4
- Primary Endpoint
- the effectiveness of a service package compared to conventional follow-up in people with heart failure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
the effectiveness of a service package compared to conventional follow-up in people with heart failure.
Time Frame: 6 months
The outcome measure is the number of hospitalization
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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