Care After Going to Intensive CareTéléRéaNCT05542329
Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit
A study testing Monitoring by Tele-Medecine in people with Care After Going to Intensive Care, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care After Going to Intensive Care
- What is being tested?
- Monitoring by Tele-Medecine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject under guardianship or curatorship
- Pregnancy / lactation
- Voluntary drug poisoning
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Service de Réanimation Médicale - CH Dijon
Dijon, 21000
Jean-Pierre QUENOT, +33 3.80.29.30.31
Service de Réanimation Médicale - CH Mulhouse
Mulhouse, 68100
Khaldoun KUTEIFAN, +33 3.89.64.86.98, kuteifank@ghrmsa.fr
Service de Réanimation Médicale - CHRU Nancy - France
Nancy, 54511
Bruno LEVY, +33 3.83.15.40.84, b.levy@chru-nancy.fr
Service de Médecine Intensive - Réanimation / CHU Strasbourg - France
Strasbourg, 67091
Julie HELMS, +33 3.69.55.13.69, julie.helms@chru-strasbourg.fr
Julie HELMS
About this study
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.
- Conditions
- Care After Going to Intensive Care
- Being tested
- Monitoring by Tele-Medecine
- Keywords
- Tele-medicine, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by Tele-MedecineDevice
Monitoring by Tele-Medecine
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Tele-Medecine | Experimental | 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 Receives: Device: Monitoring by Tele-Medecine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the medico-economic of telemedicine monitoring
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startOct 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care After Going to Intensive CareStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542329
- Sponsor's protocol ID
- 8940
- Acronym
- TéléRéa
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05542329
- Acronym / sponsor ID
- TéléRéa / 8940
- Conditions
- Care After Going to Intensive Care
- Keywords
- Tele-medicine, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Tele-Medecine | Experimental | Device: Monitoring by Tele-MedecineThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Subject under guardianship or curatorship
- Pregnancy / lactation
- Voluntary drug poisoning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring by Tele-MedecineMonitoring by Tele-Medecine | Device | Tele-Medecine |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Service de Réanimation Médicale - CHRU Nancy - France
Nancy, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by Tele-Medecine in people with Care After Going to Intensive Care, run by University Hospital, Strasbourg, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the medico-economic of telemedicine monitoring (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.