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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-11-15

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Innovative supported

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

Group Type EXPERIMENTAL

Innovative Supported

Intervention Type OTHER

addition of connected tools and stronger accompaniment to improve quality of life

conventional supported

Patients benefit from usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Innovative Supported

addition of connected tools and stronger accompaniment to improve quality of life

Intervention Type OTHER

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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No