Covid-19HAD-CovidNCT04430049
Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients
An observational study of Covid-19 and Family Members, run by University Hospital, Clermont-Ferrand at 11 sites in France.
Trial summary
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Family Members, Critical Illness
- What is being tested?
- Covid ICU containment measures
- Type of treatment
- Surgery or procedure
- How many people
- 811 participants
- Where
- 11 sitesFrance
- Study dates
- 22 Jun 2020to 9 Nov 2022
- 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: Relative of patient who was admitted in ICU and treated with mechanical ventilation or non-invasive ventilation or high flow oxygen or amine administration during 24hours at least.
Who may be able to join
- Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.
Who cannot join
- Relative who declines the enrollment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH Aurillac
Aurillac, 15000
CH Cannes
Cannes, 06150
University hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63000
Centre Jean Perrin
Clermont-Ferrand, 63000
CH Grenoble
Grenoble, 38000
CH Le Puy-en-Velay
Le Puy-en-Velay, 43000
University hopistal, Lyon
Lyon, 69000
CH Moulins
Moulins, 03000
CH Périgueux
Périgueux, 24000
CH Rodez
Rodez, 12000
CH Vichy
Vichy, 03200
About this study
Official title: Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)
Read the detailed description
Observational multicenter study
Three groups are compared:
- no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
- restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
- open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are
- to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
- to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups
- to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
- to identify the factor associated with significant symptoms of both anxiety and depression
- to identify the factor associated with significant PTSD-related symptoms
- Conditions
- Covid-19, Family Members, Critical Illness
- Being tested
- Covid ICU containment measures
- Keywords
- Covid-19, Family, Anxiety, Depression, Post-traumatic stress disorder, Intensive Care Unit, Visitation
- Medical subject headings
- COVID-19, Critical Illness, 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.
Covid ICU containment measuresProcedure or surgery
The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
| Study group | Role | What they receive |
|---|---|---|
| no visitation group | relatives cannot visit ICU patient during Covid pandemic period in France Receives: Procedure: Covid ICU containment measures | |
| restrictive visitation group | relatives have restriction to visit ICU patient during Covid pandemic period in France Receives: Procedure: Covid ICU containment measures | |
| open visitation group | relatives can visit ICU patient during no Covid period in France Receives: Procedure: Covid ICU containment measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Measured: Between 3 and 6 months
Depression
Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient.
HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Measured: Between 3 and 6 months
Secondary outcomes (1)
post-traumatic stress disorder
Impact of post traumatic stress disorder for relative of ICU patient will be measured with the Event scale revised (IES-R) assessed between 3 and 6 months after the ICU discharge of patient.
IES-R ranges from 0 to 88; higher scores indicate worse symptoms
Measured: between 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start22 Jun 2020
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
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.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430049
- Sponsor's protocol ID
- 2020 HAD-Covid
- Acronym
- HAD-Covid
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients
- ClinicalTrials.gov ID
- NCT04430049
- Acronym / sponsor ID
- HAD-Covid / 2020 HAD-Covid
- Conditions
- Covid-19, Family Members, Critical Illness
- Keywords
- Covid-19, Family, Anxiety, Depression, Post-traumatic stress disorder, Intensive Care Unit, Visitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 12 Jun 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.
To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)
Detailed description
Observational multicenter study
Three groups are compared:
- no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
- restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
- open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are
- to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
- to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups
- to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
- to identify the factor associated with significant symptoms of both anxiety and depression
- to identify the factor associated with significant PTSD-related symptoms
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no visitation group | – | Procedure: Covid ICU containment measuresrelatives cannot visit ICU patient during Covid pandemic period in France |
| restrictive visitation group | – | Procedure: Covid ICU containment measuresrelatives have restriction to visit ICU patient during Covid pandemic period in France |
| open visitation group | – | Procedure: Covid ICU containment measuresrelatives can visit ICU patient during no Covid period in France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relative of patient who was admitted in ICU and treated with mechanical ventilation or non-invasive ventilation or high flow oxygen or amine administration during 24hours at least.
Key inclusion criteria (1 listed)
- Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.
Key exclusion criteria (1 listed)
- Relative who declines the enrollment
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 |
|---|---|---|
| Covid ICU containment measuresThe french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU | Procedure or surgery | no visitation group, open visitation group, restrictive visitation group |
Primary outcome
Anxiety
Time frame: Between 3 and 6 months
Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.
Depression
Time frame: Between 3 and 6 months
Anxiety for relative of ICU patient will be measured by the Hospital Anxiety and depression scale (HADS) assessed between 3 and 6 months after the ICU discharge of patient. HADS ranges from 0 to 42; higher scores indicate worse symptoms.
1 secondary outcome
post-traumatic stress disorder
Time frame: between 3 and 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 8 Feb 2023.
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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.
11 sites 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 Family Members, run by University Hospital, Clermont-Ferrand at 11 sites 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 1 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Anxiety (time frame: Between 3 and 6 months). The study lists 2 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 8 Feb 2023.