COVID-19QUALICOVIDNCT05520047
Long-term Quality of Life and Prognostic Factors in Severe COVID-19 Patients and Their Relatives
An observational study of COVID-19 and Quality of Life, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is a prospective cohort study with multicenter retrospective data collection (CHR Metz-Thionville, Hôpital Mercy and Hôpital Bel Air). Patients hospitalized for COVID-19 in a critical care unit between March 2020 and March 2022 will be contacted by telephone 24 months after their hospitalization by a doctor or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Quality of Life, Posttraumatic Stress Disorder
- What is being tested?
- COVID19-severe Patient and family of COVID19-severe Patient
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 29 Aug 2024
- How long will I take part?
- 2 Years
- 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
- Adult, Older adult
Study population: COVID-19 severe patients
Who may be able to join
- Adult patient
- Having stayed in a critical care unit (resuscitation, continuous monitoring, intensive care) at the Regional Hosiptal Center (CHR) Metz-Thionville for COVID-19 between March 2020 and March 2022
- Having given their oral consent to participate (telephone contact), or not having objected during their lifetime to the use of their hospital data for epidemiological research (deceased patients)
- The trusted person or closest family member will also be invited to participate.
- The patients included will be those who were hospitalized in conventional critical care services, but also in functional units of so-called "ephemeral" critical care, armed in emergency in the context of a massive influx of victims (Cardiological Intensive Care, Post-Interventional Monitoring Room in the operating room, Dialysis Center).
Who cannot join
- Patient under guardianship or deprivation of liberty
- Cognitive disorders or lack of French language skills preventing response to evaluation questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Prognostic Factors of Long-term Quality of Life of Patients Hospitalized With Severe COVID-19 and Their Relatives
This is a prospective cohort study with multicenter retrospective data collection (CHR Metz-Thionville, Hôpital Mercy and Hôpital Bel Air).
Patients hospitalized for COVID-19 in a critical care unit between March 2020 and March 2022 will be contacted by telephone 24 months after their hospitalization by a doctor or intern from the intensive care unit. If the patient agrees to participate, he or she will then complete the study questionnaire items. Data concerning their hospital management between their hospitalization for COVID-19 and the 24-month call will then be extracted from their medical records.
Read the detailed description
The first wave of the global SARSCoV2 pandemic in March and April 2020 hit many regions of the world hard, including our Grand Est region, which had to reorganize its healthcare system in an emergency and in an unprecedented manner. The morbidity and mortality linked to this 1st wave is already very high, with mortality in intensive care units reaching 40% in the most affected regions.
Mortality, particularly in the short term, has long been the cornerstone of critical care evaluation. The development of resuscitation techniques in recent years has led to a substantial improvement in the survival of more and more patients, but also older and more polypathological patients. However, this hard criterion of mortality seems nowadays a little obsolete, making it prefer on the one hand the evaluation of the mortality in the longer term, but also and especially the evaluation of the quality of this survival. The interest has therefore shifted in recent years towards the long-term evaluation of criteria more focused on the patient but also on the family. Current data in pathologies such as Acute respiratory distress syndrome (ARDS) or severe sepsis concur to show that these are invariably associated with an alteration in quality of life, in all the domains of its original definition by the World Health Organization (WHO), and are at the origin of a "post-resuscitation syndrome".
COVID19 is marked in 5 to 10% of cases by a severe septic picture, with multivisceral dysfunction, and pulmonary involvement in the foreground. The existence of so-called "long COVID" clinical pictures already described in the literature and the media, and especially the obvious arrival of a second wave and perhaps others, make it necessary to study the long-term prognosis of this emerging infection.
The aim of this work is to quantify in a multimodal way the long-term quality of life of patients surviving a severe form of COVID19 and their families and to try to identify elements related to the patient, the COVID19, or the management, which predict this quality of survival. The theme concerned is on the one hand epidemiological and risk assessment for the populations, and on the other hand preventive and curative of late sequelae.
- Conditions
- COVID-19, Quality of Life, Posttraumatic Stress Disorder, Cognitive Impairment, Social Behavior
- Being tested
- COVID19-severe Patient, family of COVID19-severe Patient
- Medical subject headings
- COVID-19, Stress Disorders, Post-Traumatic, Cognitive Dysfunction, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID19-severe PatientBehavioural
Behavioral and social test assessment
family of COVID19-severe PatientBehavioural
Behavioral and social test assessment
| Study group | Role | What they receive |
|---|---|---|
| COVID19-severe Patient | modified Medical Research Council dyspnea scale (mMRC), European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L), the impact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS), the Montreal Cognitive Assessment (MoCA)- BLIND, Lawton instrumental activities of daily living (IADL) and Return to work scales Receives: Behavioral: COVID19-severe Patient | |
| family of COVID19-severe Patient | impact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS) scales Receives: Behavioral: family of COVID19-severe Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life at 2 years in patients hospitalized in the Critical Care Unit for COVID-19
The quality of life score at 2 years is assessed using the European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L) questionnaire: it is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
5 dimensions of the EQ-5D-5L scale. The dimensions assessed are: mobility, autonomy, impact on daily activities, pain and discomfort, and anxiety and depression.
Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 2 years after hospitalization for severe COVID-19
Secondary outcomes (8)
Dyspnea in patients hospitalized in the Critical Care Unit for COVID-19 using Modified Medical Research Council (mMRC) Dyspnea Scale
Modified Medical Research Council (mMRC) Dyspnea Scale : is recommended for conducting assessments of dyspnea and disability and functions as an indicator of exacerbation. The mMRC questionnaire is a 5-point scale and asks patients to rate dyspnea from 0 (absent) to 4 (dyspnea when dressing/undressing)
Measured: 2 years after hospitalization for severe COVID-19
Mortality in patients hospitalized in the Critical Care Unit for COVID-19
Vital status collected in hospital data or in public data from the French Institute of Statistics and Economic studies (INSEE)
Measured: 2 years after hospitalization for severe COVID-19
Satisfaction/quality of life in patients hospitalized in the Critical Care Unit for COVID-19
5 dimensions of the EQ-5D-5L scale. The dimensions assessed are: mobility, autonomy, impact on daily activities, pain and discomfort, and anxiety and depression.
Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 2 years after hospitalization for severe COVID-19
Posttraumatic stress in patients hospitalized in the Critical Care Unit for COVID-19
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Measured: 2 years after hospitalization for severe COVID-19
Cognitive impact in patients hospitalized in the Critical Care Unit for COVID-19 using The Montreal Cognitive Assessment (MoCA)- BLIND questionnaire
The Montreal Cognitive Assessment (MoCA)- BLIND is an adapted version of the original MoCA, a rapid screening instrument for mild cognitive dysfunction. The MoCA-BLIND assesses different cognitive domains: attention and concentration, memory, language, conceptual thinking, calculations, and orientation. It contains the same items as the original MoCA except those requiring visual abilities have been removed. Time to administer the MoCA- BLIND is approximately 5-10 minutes. The total possible score is 22 points; a score of 18 or above is considered normal. This cutoff score is suggestive as it has not been validated thus far.
Measured: 2 years after hospitalization for severe COVID-19
Social and professional impact in patients hospitalized in the Critical Care Unit for COVID-19 using Lawton INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (IADL)
Lawton INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (IADL) questionnaire. The Lawton IADL scale takes 10 to 15 minutes to administer and contains eight items, with a summary score from 0 (low function) to 8 (high function). The scale can be administered with a written questionnaire or by interview. The patient or a knowledgeable family member or caregiver may provide answers.
Measured: 2 years after hospitalization for severe COVID-19
Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using the impact of event scale-revised (IES-R) questionnaire
impact of event scale-revised (IES-R) questionnaire assesses self-reported PTSD symptomatology experienced in the past 7 days, and consists of 22 items measured on a five point Likert scale (0-4, with labels of 'Not at all' to 'Extremely').
Measured: 2 years after hospitalization for severe COVID-19
Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using Hospital Anxiety and Depression Scale (HADS) questionnaire
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Measured: 2 years after hospitalization for severe COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start10 Oct 2022
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 800 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien BARRAUD, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520047
- Sponsor's protocol ID
- 2022-02Obs-CHRMT
- Acronym
- QUALICOVID
- Status last verified
- Dec 2024
- First submitted
- 24 Aug 2022
- Last updated
- 27 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prognostic Factors of Long-term Quality of Life of Patients Hospitalized With Severe COVID-19 and Their Relatives
- ClinicalTrials.gov ID
- NCT05520047
- Acronym / sponsor ID
- QUALICOVID / 2022-02Obs-CHRMT
- Conditions
- COVID-19, Quality of Life, Posttraumatic Stress Disorder, Cognitive Impairment, Social Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 29 Aug 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.
This is a prospective cohort study with multicenter retrospective data collection (CHR Metz-Thionville, Hôpital Mercy and Hôpital Bel Air).
Patients hospitalized for COVID-19 in a critical care unit between March 2020 and March 2022 will be contacted by telephone 24 months after their hospitalization by a doctor or intern from the intensive care unit. If the patient agrees to participate, he or she will then complete the study questionnaire items. Data concerning their hospital management between their hospitalization for COVID-19 and the 24-month call will then be extracted from their medical records.
Detailed description
The first wave of the global SARSCoV2 pandemic in March and April 2020 hit many regions of the world hard, including our Grand Est region, which had to reorganize its healthcare system in an emergency and in an unprecedented manner. The morbidity and mortality linked to this 1st wave is already very high, with mortality in intensive care units reaching 40% in the most affected regions.
Mortality, particularly in the short term, has long been the cornerstone of critical care evaluation. The development of resuscitation techniques in recent years has led to a substantial improvement in the survival of more and more patients, but also older and more polypathological patients. However, this hard criterion of mortality seems nowadays a little obsolete, making it prefer on the one hand the evaluation of the mortality in the longer term, but also and especially the evaluation of the quality of this survival. The interest has therefore shifted in recent years towards the long-term evaluation of criteria more focused on the patient but also on the family. Current data in pathologies such as Acute respiratory distress syndrome (ARDS) or severe sepsis concur to show that these are invariably associated with an alteration in quality of life, in all the domains of its original definition by the World Health Organization (WHO), and are at the origin of a "post-resuscitation syndrome".
COVID19 is marked in 5 to 10% of cases by a severe septic picture, with multivisceral dysfunction, and pulmonary involvement in the foreground. The existence of so-called "long COVID" clinical pictures already described in the literature and the media, and especially the obvious arrival of a second wave and perhaps others, make it necessary to study the long-term prognosis of this emerging infection.
The aim of this work is to quantify in a multimodal way the long-term quality of life of patients surviving a severe form of COVID19 and their families and to try to identify elements related to the patient, the COVID19, or the management, which predict this quality of survival. The theme concerned is on the one hand epidemiological and risk assessment for the populations, and on the other hand preventive and curative of late sequelae.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19-severe Patient | – | Behavioral: COVID19-severe Patientmodified Medical Research Council dyspnea scale (mMRC), European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L), the impact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS), the Montreal Cognitive Assessment (MoCA)- BLIND, Lawton instrumental activities of daily living (IADL) and Return to work scales |
| family of COVID19-severe Patient | – | Behavioral: family of COVID19-severe Patientimpact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS) scales |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 severe patients
Key inclusion criteria (5 listed)
- Adult patient
- Having stayed in a critical care unit (resuscitation, continuous monitoring, intensive care) at the Regional Hosiptal Center (CHR) Metz-Thionville for COVID-19 between March 2020 and March 2022
- Having given their oral consent to participate (telephone contact), or not having objected during their lifetime to the use of their hospital data for epidemiological research (deceased patients)
- The trusted person or closest family member will also be invited to participate.
- The patients included will be those who were hospitalized in conventional critical care services, but also in functional units of so-called "ephemeral" critical care, armed in emergency in the context of a massive influx of victims (Cardiological Intensive Care, Post-Interventional Monitoring Room in the operating room, Dialysis Center).
Key exclusion criteria (2 listed)
- Patient under guardianship or deprivation of liberty
- Cognitive disorders or lack of French language skills preventing response to evaluation questionnaires
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 |
|---|---|---|
| COVID19-severe PatientBehavioral and social test assessment | Behavioural | COVID19-severe Patient |
| family of COVID19-severe PatientBehavioral and social test assessment | Behavioural | family of COVID19-severe Patient |
Primary outcome
Quality of life at 2 years in patients hospitalized in the Critical Care Unit for COVID-19
Time frame: 2 years after hospitalization for severe COVID-19
The quality of life score at 2 years is assessed using the European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L) questionnaire: it is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. 5 dimensions of the EQ-5D-5L scale. The dimensions assessed are: mobility, autonomy, impact on daily activities, pain and discomfort, and anxiety and depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
8 secondary outcomes
Dyspnea in patients hospitalized in the Critical Care Unit for COVID-19 using Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: 2 years after hospitalization for severe COVID-19
Mortality in patients hospitalized in the Critical Care Unit for COVID-19
Time frame: 2 years after hospitalization for severe COVID-19
Satisfaction/quality of life in patients hospitalized in the Critical Care Unit for COVID-19
Time frame: 2 years after hospitalization for severe COVID-19
Posttraumatic stress in patients hospitalized in the Critical Care Unit for COVID-19
Time frame: 2 years after hospitalization for severe COVID-19
Cognitive impact in patients hospitalized in the Critical Care Unit for COVID-19 using The Montreal Cognitive Assessment (MoCA)- BLIND questionnaire
Time frame: 2 years after hospitalization for severe COVID-19
Social and professional impact in patients hospitalized in the Critical Care Unit for COVID-19 using Lawton INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (IADL)
Time frame: 2 years after hospitalization for severe COVID-19
Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using the impact of event scale-revised (IES-R) questionnaire
Time frame: 2 years after hospitalization for severe COVID-19
Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: 2 years after hospitalization for severe COVID-19
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 27 Dec 2024.
- 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.
Damien BARRAUD, MD principal investigator
CHR Metz Thionville Hopital de Mercy
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 COVID-19 and Quality of Life, run by Centre Hospitalier Régional Metz-Thionville 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 5 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 27 Dec 2024. 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?
Quality of life at 2 years in patients hospitalized in the Critical Care Unit for COVID-19 (time frame: 2 years after hospitalization for severe COVID-19). 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 Dec 2024.