COVID-19IPES-CoVNCT05421182
Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
A study testing Revised Impact of Event Scale, Hospital Anxiety and Depression scale and 36-Item Short Form Survey in people with COVID-19 and Stress Disorders, Post-Traumatic, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Stress Disorders, Post-Traumatic
- What is being tested?
- Revised Impact of Event Scale, Hospital Anxiety and Depression scale and 36-Item Short Form Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2021to 30 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital
- during the second wave of COVID-19 in France
- for a serious form of COVID-19
- hospitalized more than 72 hours in ICU
- the case group is trusted person of evacuated patient. the control group is trusted person of not evacuated patient.
- Non -inclusion criteria :
- Trusted Person Refusing patient Medical Evacuation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).
The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.
The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.
Read the detailed description
The case group is trusted person of evacuated patient. The control group is trusted person of not evacuated patient.
The trusted person of the group control will be matched to trusted patient of the case group on :
their relationship with the patient (spouse/ascendant/descendant/other) and on criteria specific to the patient: sex, age range ( <75 years or ≥ 75 years), invasive ventilation and becoming at 3 months post COVID-19 (survivor / non survivor)
- Conditions
- COVID-19, Stress Disorders, Post-Traumatic
- Being tested
- Revised Impact of Event Scale, Hospital Anxiety and Depression scale, 36-Item Short Form Survey, satisfaction survey, semi-directed interview with trusted person on the general experience of the patient's medical evacuation
- Medical subject headings
- COVID-19, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revised Impact of Event ScaleOther
Also called IES-R
to measure the affect of routine life stress,everyday traumas and acute stress
Hospital Anxiety and Depression scaleOther
Also called HADS
to measure anxiety and depression
36-Item Short Form SurveyOther
Also called SF-36
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
satisfaction surveyOther
satisfaction survey of the trusted person about the communication with ICU personal
semi-directed interview with trusted person on the general experience of the patient's medical evacuationOther
interview of the trusted person about the medical evacuation : evacuation announcement;organization of the medical evacuation,; concerns related to evacuations;reception and information by the center admitting the evacuated patient; arrangements of visit, patient repatriated
semi-directed interview with trusted person on the general experience of hospitalization in intensive careOther
interview of the trusted person about ICU hospitalization: reception in ICU; ICU organization; concerns related to ICU hospitalization, information and communication with ICU staff, arrangements of visit, context of ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Interview of the trusted person of evacuated patient | Other | The interview of the trusted person of evacuated patient will be done 8 months (+/-2 months) after the medical evacuation.
The interview will be carried out by a psychologist or by a doctor from the ICU Receives: Other: Revised Impact of Event Scale; Other: Hospital Anxiety and Depression scale; Other: 36-Item Short Form Survey; Other: satisfaction survey; Other: semi-directed interview with trusted person on the general experience of the patient's medical evacuation |
| Interview of the trusted person of the not evacuated patient | Other | The interview of the trusted person of the not evacuated patient will be done 8 months (+/-2months) after the ICU admission The interview will be carried out by a psychologist or by a doctor from the ICU. Receives: Other: Revised Impact of Event Scale; Other: Hospital Anxiety and Depression scale; Other: 36-Item Short Form Survey; Other: satisfaction survey; Other: semi-directed interview with trusted person on the general experience of hospitalization in intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls).
the post-traumatic stress disorder of the trusted person is assessed by the Impact of Event Scale - Revised (IES-R), at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after Intensive Care Unit (ICU) admission for the control group
Measured: at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group
Secondary outcomes (4)
Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.
Association between medical evacuations and the occurrence of symptoms of anxiety and/or depression at 8 months in families of patients hospitalized in intensive care for a serious form of COVID19. anxiety and/or depression symptoms assessed by the Hospital Anxiety and Depresion Scale (HADS)
Measured: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Quality of Life in families of patients with severe COVID-19
Quality of Life assessed by Medical Outcomes Study Short Form 36 (SF-36)
Measured: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19
satisfaction is measured using a simple digital scale,
Measured: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.
semi-structured interview
Measured: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start30 Jun 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-Control Study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Peigne, Principal investigator, CH Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421182
- Sponsor's protocol ID
- 2021-A00805-36
- Acronym
- IPES-CoV
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study, will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
- ClinicalTrials.gov ID
- NCT05421182
- Acronym / sponsor ID
- IPES-CoV / 2021-A00805-36
- Conditions
- COVID-19, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 16 Jun 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.
At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).
The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.
The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.
Detailed description
The case group is trusted person of evacuated patient. The control group is trusted person of not evacuated patient.
The trusted person of the group control will be matched to trusted patient of the case group on :
their relationship with the patient (spouse/ascendant/descendant/other) and on criteria specific to the patient: sex, age range ( <75 years or ≥ 75 years), invasive ventilation and becoming at 3 months post COVID-19 (survivor / non survivor)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-Control Study
| Arm | Type | Receives |
|---|---|---|
| Interview of the trusted person of evacuated patient | Other | Other: Revised Impact of Event Scale, Other: Hospital Anxiety and Depression scale, Other: 36-Item Short Form Survey, Other: satisfaction survey, Other: semi-directed interview with trusted person on the general experience of the patient's medical evacuationThe interview of the trusted person of evacuated patient will be done 8 months (+/-2 months) after the medical evacuation. The interview will be carried out by a psychologist or by a doctor from the ICU |
| Interview of the trusted person of the not evacuated patient | Other | Other: Revised Impact of Event Scale, Other: Hospital Anxiety and Depression scale, Other: 36-Item Short Form Survey, Other: satisfaction survey, Other: semi-directed interview with trusted person on the general experience of hospitalization in intensive careThe interview of the trusted person of the not evacuated patient will be done 8 months (+/-2months) after the ICU admission The interview will be carried out by a psychologist or by a doctor from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital
- during the second wave of COVID-19 in France
- for a serious form of COVID-19
- hospitalized more than 72 hours in ICU
- the case group is trusted person of evacuated patient. the control group is trusted person of not evacuated patient.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Revised Impact of Event ScaleAlso: IES-Rto measure the affect of routine life stress,everyday traumas and acute stress | Other | Interview of the trusted person of evacuated patient, Interview of the trusted person of the not evacuated patient |
| Hospital Anxiety and Depression scaleAlso: HADSto measure anxiety and depression | Other | Interview of the trusted person of evacuated patient, Interview of the trusted person of the not evacuated patient |
| 36-Item Short Form SurveyAlso: SF-36SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. | Other | Interview of the trusted person of evacuated patient, Interview of the trusted person of the not evacuated patient |
| satisfaction surveysatisfaction survey of the trusted person about the communication with ICU personal | Other | Interview of the trusted person of evacuated patient, Interview of the trusted person of the not evacuated patient |
| semi-directed interview with trusted person on the general experience of the patient's medical evacuationinterview of the trusted person about the medical evacuation : evacuation announcement;organization of the medical evacuation,; concerns related to evacuations;reception and information by the center admitting the evacuated patient; arrangements of visit, patient repatriated | Other | Interview of the trusted person of evacuated patient |
| semi-directed interview with trusted person on the general experience of hospitalization in intensive careinterview of the trusted person about ICU hospitalization: reception in ICU; ICU organization; concerns related to ICU hospitalization, information and communication with ICU staff, arrangements of visit, context of ICU discharge | Other | Interview of the trusted person of the not evacuated patient |
Primary outcome
Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls).
Time frame: at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group
the post-traumatic stress disorder of the trusted person is assessed by the Impact of Event Scale - Revised (IES-R), at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after Intensive Care Unit (ICU) admission for the control group
4 secondary outcomes
Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.
Time frame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Quality of Life in families of patients with severe COVID-19
Time frame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19
Time frame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.
Time frame: at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of 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 8 Oct 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study, will not be available to other researchers
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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.
Vincent Peigne principal investigator
CH Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revised Impact of Event Scale, Hospital Anxiety and Depression scale and 36-Item Short Form Survey in people with COVID-19 and Stress Disorders, Post-Traumatic, run by Centre Hospitalier Metropole Savoie 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 7 inclusion and 0 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 Oct 2026. 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?
Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls). (time frame: at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group). 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 Oct 2026.