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

May 25, 2020 updated by: University Hospital, Grenoble

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble-Alpes
      • Grenoble, France, 38000
        • Groupe Hospitalier Mutualiste

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: 6 months
The outcome measure is the number of hospitalization
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Muriel SALVAT, MD, CHU Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC16.045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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