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CompletedNCT04385121Familles-COVIDUpdated Jul 1, 2022

Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

An observational study in Covid-19, Stress Disorders, Post-Traumatic and Anxiety, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
01

Study summary

The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

02

Conditions studied

  • Covid-19
  • Stress Disorders, Post-Traumatic
  • Anxiety
  • Depression

Keywords

  • COVID-19
  • Psychological impact
  • Family members
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 88 is below the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 989 studies on the registry; 348 are open to participants now.

Browse University Hospital, Strasbourg, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Family members of COVID+ patient

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition.
  • A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner.
  • The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor.

Exclusion criteria

Exclusion Criteria:

  • Difficulties in understanding French
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)
Patient registry
No

Interventions

  • OtherQuestionnary

    Family member's will answer the questionnaires by phone

06

What researchers measure

Primary outcomes

  1. Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))

    An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R)

    Time frame: 3 months

07

Study locations

1 site
  • Les Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
08

References and documents

Publications

  • Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrie M, Aquin C, Buis G, Gehant E, Granier A, Kercha H, Le Guillou C, Martin G, Roulot K, Meziani F, Putois O, Helms J. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021 Jan 9;9(1):5. doi: 10.1186/s40560-020-00520-w. PubMed 33422153 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2020 to primary completion in Apr 2020, 0 months.

Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 0 months is below that.

Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2020
First posted
May 12, 2020
StartActual
Apr 16, 2020
Primary completionActual
Apr 16, 2020
CompletionActual
May 15, 2020
Last update
Jul 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04385121
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
May 12, 2020
Start date
Apr 16, 2020
Primary completion
Apr 16, 2020
Completion
May 15, 2020
Last update
Jul 1, 2022

Study contacts

Julie HELMS
principal investigator · CHU de Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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