Batch n ° 2 of the Public Market Evaluation "Medico-economic Demonstrator IsereADOM" (CardIC)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Heart Failure

Treatments: Other: Innovative Supported

Study type: Interventional

Funder types: Other

Identifiers

NCT03457623

38RC16.045

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Innovative supported

Experimental group

Description:

In addition to usual care, patients benefit from connected tools (overpoise, sphygmomanometer...), physical activity, a strong accompaniment with a referent person

Treatment:

Other: Innovative Supported

conventional supported

No Intervention group

Description:

Patients benefit from usual care