Health-related Quality of LifeCritiQoL2NCT05111522
Health-related Quality of Life and Functional Impairments After Intensive Care Unit Discharge
An observational study of Health-related Quality of Life, run by Versailles Hospital at 1 site in France.
Trial summary
Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Health-related Quality of Life
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Jan 2026
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients who meet the eligibility criteria will be offered participation in the study.
Who may be able to join
- all adult patients(age>18) hospitalized in ICU
Who cannot join
- legal guardianship
- opposition to participate
- unread and unwritten French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study
Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.
Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.
Read more
Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.
Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.
Read the detailed description
The investigators therefore propose the constitution of a longitudinal cohort evaluating the HRQoL, and allowing the analysis of its determinants in the global population of intensive care patients.
- Conditions
- Health-related Quality of Life
- Keywords
- Health-related quality of life, Morbidity, Long terms outcomes, Post intensive care syndrome, Intensive Care Unit
- Medical subject headings
- postintensive care syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales :
i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap.
Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
The Fatigue Severity Scale(fatigue)-Ranging score[9-63],a high score indicate a greater fatigue severity.
The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
Measured: 24month
Secondary outcomes (1)
Presence or not of elements associated with i) HRQOL impairements defined by ii)physical and/or psychological and /or cognitive impairments in the global population and in differents sub-groups of interest, according to the to following scales :
i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap.
Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
The Fatigue Severity Scale(fatigue)-Ranging score[9-63],a high score indicate a greater fatigue severity.
The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale-Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal..
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Legriel Stéphane
- Responsible party
- Principal investigator, Jacq Gwenaelle, Versailles Hospital
- Investigators
- Gwenaëlle JACQ, RN,MSc, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111522
- Sponsor's protocol ID
- P21/07_CritiQol2
- Acronym
- CritiQoL2
- Status last verified
- Jul 2022
- First submitted
- 28 Sep 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05111522
- Acronym / sponsor ID
- CritiQoL2 / P21/07_CritiQol2
- Conditions
- Health-related Quality of Life
- Keywords
- Health-related quality of life, Morbidity, Long terms outcomes, Post intensive care syndrome, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Legriel Stéphane
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Nov 2021 (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.
Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.
Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.
Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.
Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.
Detailed description
The investigators therefore propose the constitution of a longitudinal cohort evaluating the HRQoL, and allowing the analysis of its determinants in the global population of intensive care patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who meet the eligibility criteria will be offered participation in the study.
Key inclusion criteria (1 listed)
- all adult patients(age>18) hospitalized in ICU
Key exclusion criteria (3 listed)
- legal guardianship
- opposition to participate
- unread and unwritten French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales :
Time frame: 24month
i)36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status. ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap. Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency. The Fatigue Severity Scale(fatigue)-Ranging score[9-63],a high score indicate a greater fatigue severity. The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considered normal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
1 secondary outcome
Presence or not of elements associated with i) HRQOL impairements defined by ii)physical and/or psychological and /or cognitive impairments in the global population and in differents sub-groups of interest, according to the to following scales :
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- 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.
Gwenaëlle JACQ, RN,MSc principal investigator
Versailles Hospital
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 Health-related Quality of Life, run by Versailles Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwenaëlle JACQ, RN, MSc (0139638356, gjacq@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of an overall HRQOL and ii) percentage functional impairments in the global population of intensive care unit survivors,2 years after ICU discharge.according to the score to following scales : (time frame: 24month). 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 27 Jul 2022.