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Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19 (IPES-CoV)

Primary Purpose

COVID-19, Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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
semi-directed interview with trusted person on the general experience of hospitalization in intensive care
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • CH Metropole Savoie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Interview of the trusted person of evacuated patient

Interview of the trusted person of the not evacuated patient

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Quality of Life in families of patients with severe COVID-19
Quality of Life assessed by Medical Outcomes Study Short Form 36 (SF-36)
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,
Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.
semi-structured interview

Full Information

First Posted
June 14, 2022
Last Updated
June 16, 2022
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT05421182
Brief Title
Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
Acronym
IPES-CoV
Official Title
Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case-Control Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interview of the trusted person of evacuated patient
Arm Type
Other
Arm Description
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
Arm Title
Interview of the trusted person of the not evacuated patient
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Revised Impact of Event Scale
Other Intervention Name(s)
IES-R
Intervention Description
to measure the affect of routine life stress,everyday traumas and acute stress
Intervention Type
Other
Intervention Name(s)
Hospital Anxiety and Depression scale
Other Intervention Name(s)
HADS
Intervention Description
to measure anxiety and depression
Intervention Type
Other
Intervention Name(s)
36-Item Short Form Survey
Other Intervention Name(s)
SF-36
Intervention Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Intervention Type
Other
Intervention Name(s)
satisfaction survey
Intervention Description
satisfaction survey of the trusted person about the communication with ICU personal
Intervention Type
Other
Intervention Name(s)
semi-directed interview with trusted person on the general experience of the patient's medical evacuation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
semi-directed interview with trusted person on the general experience of hospitalization in intensive care
Intervention Description
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
Primary Outcome Measure Information:
Title
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).
Description
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
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
Secondary Outcome Measure Information:
Title
Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.
Description
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)
Time Frame
at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Title
Quality of Life in families of patients with severe COVID-19
Description
Quality of Life assessed by Medical Outcomes Study Short Form 36 (SF-36)
Time Frame
at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Title
Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19
Description
satisfaction is measured using a simple digital scale,
Time Frame
at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.
Title
Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.
Description
semi-structured interview
Time Frame
at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Peigne
Organizational Affiliation
CH Metropole Savoie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Metropole Savoie
City
Chambéry
ZIP/Postal Code
73000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) collected in this study, will not be available to other researchers

Learn more about this trial

Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

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