Clinical trial NCT03457623: Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM"
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: the effectiveness of a service package compared to conventional follow-up in people with heart failure.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Muriel SALVAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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