Critical IllnessNCT04498507
Psychosocial Outcomes in Families of COVID-19 ICU Patients
An observational study of Critical Illness and Family, run by University of Liege at 1 site in Belgium.
Trial summary
During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Family, Psychological Stress
- What is being tested?
- HADS questionnaire
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2020to 30 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: this study includes the family members of patients who were admitted in ICU for sever COVID-19 during the first part of the pandemic when visits in ICU were not allowed
Who may be able to join
- the referent family member of any patient admitted in ICU for COVID-19 during the first part of the pandemic
Who cannot join
- cognitive disorders
- not French-speaking
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium
During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.
- Conditions
- Critical Illness, Family, Psychological Stress, Covid19
- Being tested
- HADS questionnaire
- Medical subject headings
- Critical Illness, Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HADS questionnaireDiagnostic test
Also called IES-R questionnaire, EQ-5D questionnaire
Patients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of anxiety and depression
sub scores of HADS questionnaire >7
Measured: one month after ICU discharge
occurence of anxiety and depression
sub scores of HADS questionnaire >7
Measured: three months after ICU discharge
occurence of acute stress
IES-R score > 22
Measured: one month after ICU discharge
occurence of post-traumatic stress disorder
IES-R score > 36
Measured: three months after ICU discharge
quality of life
assessed using the EQ-5D questionnaire
Measured: one month after ICU discharge
quality of life
assessed using the EQ-5D questionnaire
Measured: three months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start16 Apr 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498507
- Sponsor's protocol ID
- Family COVID
- Status last verified
- Nov 2020
- First submitted
- 1 Aug 2020
- Last updated
- 3 Nov 2020
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium
- ClinicalTrials.gov ID
- NCT04498507
- Acronym / sponsor ID
- Family COVID
- Conditions
- Critical Illness, Family, Psychological Stress, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 4 Aug 2020 (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.
During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- this study includes the family members of patients who were admitted in ICU for sever COVID-19 during the first part of the pandemic when visits in ICU were not allowed
Key inclusion criteria (1 listed)
- the referent family member of any patient admitted in ICU for COVID-19 during the first part of the pandemic
Key exclusion criteria (3 listed)
- cognitive disorders
- not French-speaking
- refusal to participate
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 |
|---|---|---|
| HADS questionnaireAlso: IES-R questionnaire, EQ-5D questionnairePatients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life | Diagnostic test | – |
Primary outcome
occurence of anxiety and depression
Time frame: one month after ICU discharge
sub scores of HADS questionnaire >7
occurence of anxiety and depression
Time frame: three months after ICU discharge
sub scores of HADS questionnaire >7
occurence of acute stress
Time frame: one month after ICU discharge
IES-R score > 22
occurence of post-traumatic stress disorder
Time frame: three months after ICU discharge
IES-R score > 36
quality of life
Time frame: one month after ICU discharge
assessed using the EQ-5D questionnaire
quality of life
Time frame: three months after ICU discharge
assessed using the EQ-5D questionnaire
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 3 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Illness and Family, run by University of Liege at 1 site in Belgium.
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: finished, as of the sponsor's last update on 3 Nov 2020. 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 Belgium. 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?
occurence of anxiety and depression (time frame: one month after ICU discharge). The study lists 6 primary outcomes in all. 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 3 Nov 2020.