Quality of LifePromorea-qolNCT05527678
5 Years Quality of Life and Early Mobilization in ICU
An observational study of Quality of Life and ICU Acquired Weakness, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge. The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, ICU Acquired Weakness, Morality
- What is being tested?
- Questionnaires
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2022to 2 May 2023
- Phase
- Observational
- 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
Study population: All patients who participated in the PROMOREA 1 study, whose vital status is "alive" at least 5 years after their discharge from the ICU (INSEE file, MatchID search engine, https://deces.matchid.io/search?fuzzy=false), will be recontacted by mail at the last known address and by phone at the last known number if they do not answer the mail.
Who may be able to join
- Have participated in the Promorea1 study
- Alive at the time the questionnaires were sent
Who cannot join
- Opposition to the use of vital status data
- Extra-national patient not on the national registry
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional d'Orléans
Orléans, Centre-Val de Loire, 45067
About this study
Official title: Assessment of Quality of Life in Patients Who Participated in the Promorea 1 Study
In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge.
The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort.
The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55.
The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.
Read the detailed description
Study design Prospective, observational study.
- Research of vital status
- Completion of two questionnaires (Short Form-36 and Katz Index of Independence in Activities of Daily Living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.
- Conditions
- Quality of Life, ICU Acquired Weakness, Morality
- Being tested
- Questionnaires
- Keywords
- ICU, Quality of life, Medical research council sum score, Mortality, early mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Written or by phone
| Study group | Role | What they receive |
|---|---|---|
| 5 years ICU survivors | Survivors 5 years after ICU and who participated in the Promorea1 study will be contacted to assess their quality of life. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years mortality
Vital status
Measured: Before sending questionnaires
Secondary outcomes (2)
Medical Outcomes Study 36-item Short-Form Health Survey
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study.
It comprises 36 questions which cover eight domains of health.
The recommended scoring system for the SF-36 is a weighted Likert system for each item. Items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale from 0 (negative to health) to 100 (favorable to health) to obtain a score for each subscale.
Measured: through study completion, an average of 6 months
Katz Index of Independence in Activities of Daily Living questionnaire
The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions.
A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
The instrument is most effectively used among older adults in a variety of care settings, when baseline measurements, taken when the client is well, are compared to periodic or subsequent measures.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start28 Oct 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FOSSAT, Pt Msc, Principal investigator, Centre Hospitalier Régional d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527678
- Sponsor's protocol ID
- CHRO-2022-02
- Acronym
- Promorea-qol
- Status last verified
- May 2023
- First submitted
- 30 Aug 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.
PubMed 30043066Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.
PubMed 31970446
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Patients Who Participated in the Promorea 1 Study
- ClinicalTrials.gov ID
- NCT05527678
- Acronym / sponsor ID
- Promorea-qol / CHRO-2022-02
- Conditions
- Quality of Life, ICU Acquired Weakness, Morality
- Keywords
- ICU, Quality of life, Medical research council sum score, Mortality, early mobilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 2 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.
In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge.
The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort.
The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55.
The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.
Detailed description
Study design Prospective, observational study.
- Research of vital status
- Completion of two questionnaires (Short Form-36 and Katz Index of Independence in Activities of Daily Living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5 years ICU survivors | – | Other: QuestionnairesSurvivors 5 years after ICU and who participated in the Promorea1 study will be contacted to assess their quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who participated in the PROMOREA 1 study, whose vital status is "alive" at least 5 years after their discharge from the ICU (INSEE file, MatchID search engine, https://deces.matchid.io/search?fuzzy=false), will be recontacted by mail at the last known address and by phone at the last known number if they do not answer the mail.
Key inclusion criteria (2 listed)
- Have participated in the Promorea1 study
- Alive at the time the questionnaires were sent
Key exclusion criteria (2 listed)
- Opposition to the use of vital status data
- Extra-national patient not on the national registry
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 |
|---|---|---|
| QuestionnairesWritten or by phone | Other | 5 years ICU survivors |
Primary outcome
5 years mortality
Time frame: Before sending questionnaires
Vital status
2 secondary outcomes
Medical Outcomes Study 36-item Short-Form Health Survey
Time frame: through study completion, an average of 6 months
Katz Index of Independence in Activities of Daily Living questionnaire
Time frame: through study completion, an average of 6 months
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 17 May 2023.
- Results publication: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Results publication: PubMed 30043066Fossat G, Baudin F, Courtes L, Bobet S, Dupont A, Bretagnol A, Benzekri-Lefevre D, Kamel T, Muller G, Bercault N, Barbier F, Runge I, Nay MA, Skarzynski M, Mathonnet A, Boulain T. Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. JAMA. 2018 Jul 24;320(4):368-378. doi: 10.1001/jama.2018.9592.
- Results publication: PubMed 31970446Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.
- Individual participant dataSharing planned: No
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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.
Guillaume FOSSAT, Pt Msc principal investigator
Centre Hospitalier Régional d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and ICU Acquired Weakness, run by Centre Hospitalier Régional d'Orléans 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 2 inclusion and 2 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 17 May 2023. 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?
5 years mortality (time frame: Before sending questionnaires). 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 NCT05527678, which also lists 3 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 17 May 2023.