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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03457623

Acronym

CardIC

Enrollment

Registered

2018-03-07

Start date

2017-11-20

Completion date

2019-11-15

Last updated

2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERInnovative Supported

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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).

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026