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

NCT ID: NCT05542329

Last Updated: 2024-07-18

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Care After Going to Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Monitoring by Tele-Medecine

Intervention Type DEVICE

Monitoring by Tele-Medecine

Interventions

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Monitoring by Tele-Medecine

Monitoring by Tele-Medecine

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Réanimation Médicale - CH Dijon

Dijon, , France

Site Status

Service de Réanimation Médicale - CH Mulhouse

Mulhouse, , France

Site Status

Service de Réanimation Médicale - CHRU Nancy - France

Nancy, , France

Site Status

Service de Médecine Intensive - Réanimation / CHU Strasbourg - France

Strasbourg, , France

Site Status

Countries

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France

Facility Contacts

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Jean-Pierre QUENOT

Role: primary

+33 3.80.29.30.31

Khaldoun KUTEIFAN

Role: primary

+33 3.89.64.86.98

Bruno LEVY

Role: primary

+33 3.83.15.40.84

Julie HELMS

Role: primary

+33 3.69.55.13.69

Other Identifiers

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8940

Identifier Type: -

Identifier Source: org_study_id

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