Batch n ° 2 of the Public Market Evaluation Medico-economic Demonstrator IsereADOM

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Innovative Supported


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Innovative supported<br>In addition to usual care, patients benefit from connected tools (overpoise, sphygmomanometer...), physical activity, a strong accompaniment with a referent person | Other: Innovative Supported<br>* addition of connected tools and stronger accompaniment to improve quality of life<br>|
| No Intervention: conventional supported<br>Patients benefit from usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness of a service package compared to conventional follow-up in people with heart failure. | The outcome measure is the number of hospitalization | 6 months |