Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit (TéléRéa)

July 17, 2024 updated by: University Hospital, Strasbourg, France

Patients surviving to a stay in intensive care unit (ICU) are likely to require specific care and follow-up after their ICU stay, in order to manage the serious illness at the origin of the ICU stay and any sequelae, but also to adapt the treatments and prevent new complications. At present, there is no specific care chain after ICU.

In order to meet this need, we propose the implementation of a care chain integrating telemedicine at home. We compare the current system (lack of specific follow-up) to follow-up by telemedicine at home.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

448

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
      • Dijon, France, 21000
        • Service de Réanimation Médicale - CH Dijon
        • Contact:
          • Jean-Pierre QUENOT
          • Phone Number: +33 3.80.29.30.31
      • Mulhouse, France, 68100
        • Service de Réanimation Médicale - CH Mulhouse
        • Contact:
      • Nancy, France, 54511
        • Service de Réanimation Médicale - CHRU Nancy - France
        • Contact:
      • Strasbourg, France, 67091
        • Service de Médecine Intensive - Réanimation / CHU Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Julie HELMS

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Adult patient ≥ 18 years old
  • Patient admitted to ICU
  • Stay in intensive care > 48h
  • Patient having benefited from at least one organ support during the ICU stay: invasive or non-invasive ventilation (including nasal high-flow oxygen therapy), inotropic or vasopressor support, renal replacement therapy)
  • Understanding of the French language
  • Patient or entourage able to carry out the measures proposed by telemedicine
  • Subject affiliated to a social health insurance scheme
  • Subject having signed a consent form

Exclusion criteria:

  • Subject under guardianship or curatorship
  • Pregnancy / lactation
  • Voluntary drug poisoning

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard of care
Experimental: Tele-Medecine
The experimental group will be given a case of connected devices dedicated to telemedicine allowing them to closely monitor their state of health during the 3 months following discharge from hospital
Device: Monitoring by Tele-Medecine
Monitoring by Tele-Medecine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the medico-economic of telemedicine monitoring
Time Frame: 12 month
The main judgment criterion will be the incremental cost-utility ratio of the innovation represented by monitoring by a telemedicine device linked to a nurse coordination unit, compared to the usual monitoring without telemedicine.
12 month

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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