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Completed

NCT Number: NCT05421182

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Metropole Savoie

Chambéry, 73000, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revised Impact of Event Scale

Other

to measure the affect of routine life stress,everyday traumas and acute stress

Other names: IES-R

Hospital Anxiety and Depression Scale

Other

to measure anxiety and depression

Other names: HADS

36-Item Short Form Survey

Other

SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.

Other names: SF-36

satisfaction survey

Other

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 evacuation

Other

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 care

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

    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)

  2. 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.

    Quality of Life assessed by Medical Outcomes Study Short Form 36 (SF-36)

  3. 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.

    satisfaction is measured using a simple digital scale,

  4. 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.

    semi-structured interview

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Acronym: IPES-CoV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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