Status:
COMPLETED
Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Heart Failure
Eligibility:
All Genders
60+ years
Phase:
NA
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 goa...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03457623
Start Date
November 20 2017
End Date
November 15 2019
Last Update
May 27 2020
Active Locations (2)
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1
Groupe Hospitalier Mutualiste
Grenoble, France, 38000
2
CHU Grenoble-Alpes
Grenoble, France, 38043