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OpenTrials
Completed

NCT Number: NCT03457623

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

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble-Alpes, Grenoble, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Innovative Supported

Other

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

Primary outcomes

  1. the effectiveness of a service package compared to conventional follow-up in people with heart failure.

    Time frame: 6 months

    The outcome measure is the number of hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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.

Acronym: CardIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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