Quality of LifeSUIVI-REANCT01796509
Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors
A study testing Medical, psychological, social in people with Quality of Life and Post ICU Discharge, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Study Hypothesis: Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Post ICU Discharge
- What is being tested?
- Medical, psychological, social
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women older than 18
- Living in an area near the hospital
- Hospitalized in the ICU medical surgical hospitals in this study.
- Who required mechanical ventilation more than 3 days
- Having a life expectancy greater than one year (Mc Cabe score >2, absence of metastatic cancer)
- Having a general practitioner identified
- Is affiliated to a social health care
- And who have given their written informed consent
Who cannot join
- Patients hospitalized in ICU in the previous year
- Patients followed for a preexisting myopathy
- The burn patients, patients with brain injury (Glasgow initial <8) or trauma
- Patients hospitalized for suicide or self-induced poisoning
- Patients with psychiatric disorders
- Patients with ore dementia
Show all 11Show fewer
- Pregnant women
- Patients who do not speak fluently French
- Patients with guardianship
- Homeless patients
- No having a general practitioner identified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors
Study Hypothesis:
Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU).
Primary Purpose:
Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.
Read the detailed description
Critically ill patients who had required at least 3 days of mechanical ventilation and who consented to participate will be randomized at time of ICU discharge in either follow-up or not follow-up arm. The medical, psychological and social follow-up consists of multidisciplinary consultation at time of ICU discharge (i.e. inclusion), at three, six and 12 months afterward. Patients of the "non follow-up group" will be seen only at one year. Medical consultation will be focused on evaluation of pre-existing co-morbidities, detection of new ones and of physical disorders related to critical illness (i.e. ICU-acquired paresis, pain, functional disability, cognitive dysfunction…). Psychological assessment will be focused on detection of anxiety, depression and post-traumatic stress syndrome. Social follow-up will assess the social need of the patient in the professional and private domains. Each assessment will be standardized by using validated or appropriate scores. At the end of each multidisciplinary consultation, a report will be sent to the patient and his general practitioner. When necessary, a consultation with a specialist will be organized. At one year, an observer blinded from randomization will call all the patients to assess their quality of life with help of EQ5D questionnaire. Economical cost of multidisciplinary follow-up will be assessed.
To our knowledge, there is no follow-up studies that have combined a medical, psychological and social cares. For instance, the PracTical study has not evidenced an improvement of quality of life in patients who had beneficiated from nurse consultations at 3 and 9 months.
- Conditions
- Quality of Life, Post ICU Discharge
- Being tested
- Medical, psychological, social
- Keywords
- Quality of life,, Sequela disorders,, Socio-professional impact,, Anxiety, depression,, Post traumatic stress disorder,, ICU acquired paresis.
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical, psychological, socialOther
After having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary follow-up | Experimental | Not described Receives: Other: Medical, psychological, social |
| no follow-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or severe alteration of quality of life assessed after ICU discharge
Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.
Measured: 1 year
Secondary outcomes (4)
Assessment of life quality in Medical domain
ICU-acquired paresis assessed with help of MRC sum score, Functional disabilities assessed with help of Barthel and IADL scales, Cognitive dysfunctions assessed with help of MMS score, Pain, Comorbidities (Hypertension, etc…).
Measured: 1 year
Assessment in psychological domain
Anxiety assessed with help of HAD scale, Depression assessed with help of HAD scale Post-traumatic stress syndrome assessed with help of IES scale.
Measured: 1 year
Assessment in social domain
Social reinsertion with help of RNLI scale.
Measured: 1 year
Assessment in economical cost
Number of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2018
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek Sharshar, MD, PHD, Study director, ICU, Hôpital Raymond PoincaréDiane Friedman, MD, Principal investigator, ICU, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796509
- Sponsor's protocol ID
- P100147
- Acronym
- SUIVI-REA
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2013
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharshar T, Grimaldi-Bensouda L, Siami S, Cariou A, Salah AB, Kalfon P, Sonneville R, Meunier-Beillard N, Quenot JP, Megarbane B, Gaudry S, Oueslati H, Robin-Lagandre S, Schwebel C, Mazeraud A, Annane D, Nkam L, Friedman D; Suivi-Rea Investigators. A randomized clinical trial to evaluate the effect of post-intensive care multidisciplinary consultations on mortality and the quality of life at 1 year. Intensive Care Med. 2024 May;50(5):665-677. doi: 10.1007/s00134-024-07359-x. Epub 2024 Apr 8.
PubMed 38587553Friedman D, Grimaldi L, Cariou A, Aegerter P, Gaudry S, Ben Salah A, Oueslati H, Megarbane B, Meunier-Beillard N, Quenot JP, Schwebel C, Jacob L, Robin Lagandre S, Kalfon P, Sonneville R, Siami S, Mazeraud A, Sharshar T. Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.
PubMed 35532996
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors
- ClinicalTrials.gov ID
- NCT01796509
- Acronym / sponsor ID
- SUIVI-REA / P100147
- Conditions
- Quality of Life, Post ICU Discharge
- Keywords
- Quality of life,, Sequela disorders,, Socio-professional impact,, Anxiety, depression,, Post traumatic stress disorder,, ICU acquired paresis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 21 Feb 2013 (estimated)
- 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.
Study Hypothesis:
Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU).
Primary Purpose:
Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.
Detailed description
Critically ill patients who had required at least 3 days of mechanical ventilation and who consented to participate will be randomized at time of ICU discharge in either follow-up or not follow-up arm. The medical, psychological and social follow-up consists of multidisciplinary consultation at time of ICU discharge (i.e. inclusion), at three, six and 12 months afterward. Patients of the "non follow-up group" will be seen only at one year. Medical consultation will be focused on evaluation of pre-existing co-morbidities, detection of new ones and of physical disorders related to critical illness (i.e. ICU-acquired paresis, pain, functional disability, cognitive dysfunction…). Psychological assessment will be focused on detection of anxiety, depression and post-traumatic stress syndrome. Social follow-up will assess the social need of the patient in the professional and private domains. Each assessment will be standardized by using validated or appropriate scores. At the end of each multidisciplinary consultation, a report will be sent to the patient and his general practitioner. When necessary, a consultation with a specialist will be organized. At one year, an observer blinded from randomization will call all the patients to assess their quality of life with help of EQ5D questionnaire. Economical cost of multidisciplinary follow-up will be assessed.
To our knowledge, there is no follow-up studies that have combined a medical, psychological and social cares. For instance, the PracTical study has not evidenced an improvement of quality of life in patients who had beneficiated from nurse consultations at 3 and 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary follow-up | Experimental | Other: Medical, psychological, social |
| no follow-up | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women older than 18
- Living in an area near the hospital
- Hospitalized in the ICU medical surgical hospitals in this study.
- Who required mechanical ventilation more than 3 days
- Having a life expectancy greater than one year (Mc Cabe score >2, absence of metastatic cancer)
Key exclusion criteria (11 listed)
- Patients hospitalized in ICU in the previous year
- Patients followed for a preexisting myopathy
- The burn patients, patients with brain injury (Glasgow initial <8) or trauma
- Patients hospitalized for suicide or self-induced poisoning
- Patients with psychiatric disorders
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 |
|---|---|---|
| Medical, psychological, socialAfter having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed. | Other | multidisciplinary follow-up |
Primary outcome
Death or severe alteration of quality of life assessed after ICU discharge
Time frame: 1 year
Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.
4 secondary outcomes
Assessment of life quality in Medical domain
Time frame: 1 year
Assessment in psychological domain
Time frame: 1 year
Assessment in social domain
Time frame: 1 year
Assessment in economical cost
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 38587553Sharshar T, Grimaldi-Bensouda L, Siami S, Cariou A, Salah AB, Kalfon P, Sonneville R, Meunier-Beillard N, Quenot JP, Megarbane B, Gaudry S, Oueslati H, Robin-Lagandre S, Schwebel C, Mazeraud A, Annane D, Nkam L, Friedman D; Suivi-Rea Investigators. A randomized clinical trial to evaluate the effect of post-intensive care multidisciplinary consultations on mortality and the quality of life at 1 year. Intensive Care Med. 2024 May;50(5):665-677. doi: 10.1007/s00134-024-07359-x. Epub 2024 Apr 8.
- Derived from this study: PubMed 35532996Friedman D, Grimaldi L, Cariou A, Aegerter P, Gaudry S, Ben Salah A, Oueslati H, Megarbane B, Meunier-Beillard N, Quenot JP, Schwebel C, Jacob L, Robin Lagandre S, Kalfon P, Sonneville R, Siami S, Mazeraud A, Sharshar T. Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.
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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. This study is not recruiting at the moment.
Tarek Sharshar, MD, PHD study director
ICU, Hôpital Raymond Poincaré
Diane Friedman, MD principal investigator
ICU, Hôpital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical, psychological, social in people with Quality of Life and Post ICU Discharge, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 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: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or severe alteration of quality of life assessed after ICU discharge (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796509, which also lists 2 linked publications.
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 5 Jan 2022; AzTrials last refreshed its copy on 28 Oct 2026.