search
Back to results

Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement. (OLAF)

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phone call
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring intensive care unit, confinement, SARS-CoV-2, post-traumatic stress disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Contact person (defined as the person that bring a support to the patient et with who the patient had close relationship) aged from more than 18 years old of a patient hospitalized during the confinement and the restricted visited during the SARS-CoV2 pandemic. Two contact persons maximum will be included by patient.
  • Affiliated to the social security
  • Agreed to participated by oral consent

Exclusion Criteria:

  • Physical visits permitted by the end of the confinement
  • Language barrier
  • Sensorial handicap (blindness or deafness) compromising the comprehension of the information
  • Legal protection of adults
  • Refusal of participation

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OLAF group

Control

Arm Description

The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team.

The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution.

Outcomes

Primary Outcome Measures

incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.

Secondary Outcome Measures

incidence of PTSD observed 6 months after patient's death in the intensive care unit
The incidence of PTSD 6 months after patient's death in the intensive care unit
PTSD incidence at month 3
The incidence of PTSD 3 months after the death or discharge from the intensive care unit
PTSD incidence at month 12
The incidence of PTSD 12 months after the death or discharge from the intensive care unit
Symptoms incidence at month 3
The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit
Symptoms incidence at month 6
The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit
Symptoms incidence at month 12
The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit
incidence of persistent complicated grief at month 3
The incidence of persistent complicated grief 3 months after death in intensive care
incidence of persistent complicated grief at month 6
The incidence of persistent complicated grief 6 months after death in intensive care
incidence of persistent complicated grief at month 12
The incidence of persistent complicated grief 12 months after death in intensive care

Full Information

First Posted
July 3, 2020
Last Updated
May 30, 2022
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT04470869
Brief Title
Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.
Acronym
OLAF
Official Title
Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

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

5. Study Description

Brief Summary
The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.
Detailed Description
The hospitalization of a relative in an intensive care unit is an important stress factor for his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD) following the ICU stay of their loved ones. To response to this issue specific approach have been designed to decrease the stress of the relatives named family centered care. Those approaches are based on the interaction between the ICU team and the relatives and included large time for visiting the patient in the ward. In France the restrictive measures (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted negatively those family centered care approach by prohibiting the visit in ICU and limiting to interaction between ICU team and relatives to phone calls. The investigators thought that this context could have for consequence an increase in relative anxiety and PTSD. The investigators designed a care intervention named OLAF in order to limit the impact of the confinement on relative psychological state. OLAF intervention permits to the two closest relatives of the patient to be contacted by a psychiatrist and could benefit from a specialized follow up. This intervention is completed by the implementation of virtual visits by video conference that were proposed to the relatives as well as video interview with the ICU team. In this study the investigators aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention. The relative will benefit from psychiatric interview 3 months after their loved ones leave the ICU or died to collect information by phone about the confinement situation they experiment, the satisfaction they had about the patient stay in ICU and their anxiety and depression state. Three-month, six month and twelve months after the discharge of the dead the relative information will be collected by phone about PTSD symptoms, anxiety and depression and complicated grief in case of death of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
intensive care unit, confinement, SARS-CoV-2, post-traumatic stress disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OLAF group
Arm Type
Experimental
Arm Description
The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution.
Intervention Type
Other
Intervention Name(s)
Phone call
Intervention Description
The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.
Primary Outcome Measure Information:
Title
incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
Description
To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
incidence of PTSD observed 6 months after patient's death in the intensive care unit
Description
The incidence of PTSD 6 months after patient's death in the intensive care unit
Time Frame
Month 6
Title
PTSD incidence at month 3
Description
The incidence of PTSD 3 months after the death or discharge from the intensive care unit
Time Frame
Month 3
Title
PTSD incidence at month 12
Description
The incidence of PTSD 12 months after the death or discharge from the intensive care unit
Time Frame
Month 12
Title
Symptoms incidence at month 3
Description
The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit
Time Frame
Month 3
Title
Symptoms incidence at month 6
Description
The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit
Time Frame
Month 6
Title
Symptoms incidence at month 12
Description
The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit
Time Frame
Month 12
Title
incidence of persistent complicated grief at month 3
Description
The incidence of persistent complicated grief 3 months after death in intensive care
Time Frame
Month 3
Title
incidence of persistent complicated grief at month 6
Description
The incidence of persistent complicated grief 6 months after death in intensive care
Time Frame
Month 6
Title
incidence of persistent complicated grief at month 12
Description
The incidence of persistent complicated grief 12 months after death in intensive care
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Contact person (defined as the person that bring a support to the patient et with who the patient had close relationship) aged from more than 18 years old of a patient hospitalized during the confinement and the restricted visited during the SARS-CoV2 pandemic. Two contact persons maximum will be included by patient. Affiliated to the social security Agreed to participated by oral consent Exclusion Criteria: Physical visits permitted by the end of the confinement Language barrier Sensorial handicap (blindness or deafness) compromising the comprehension of the information Legal protection of adults Refusal of participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette SALLES, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.

We'll reach out to this number within 24 hrs