NCT04667962

Brief Summary

The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers. The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

December 13, 2020

Last Update Submit

November 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Burn-out Assessment tool (BAT) score at enrollment.

    Burn-out Assessment tool (BAT) score at enrollment will be compared between the "hospital service change" group and the "no hospital service change" group.

    At enrollment

Study Arms (2)

Hospital service change

This group is composed of caregivers who changed hospital service during COVID-19 health crisis.

Other: Online questionnaire

No hospital service change

This group is composed of caregivers who have not changed hospital service during COVID-19 health crisis.

Other: Online questionnaire

Interventions

Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.

Hospital service changeNo hospital service change

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of caregivers from the French Armed Forces Health Service (Medical doctor, nurse, assistant nurse, ...) who have been in employment when the COVID-19 health crisis began in France.

You may qualify if:

  • To be caregivers
  • Have been in employment between March 15 and May 15, 2020

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, 91223, France

Location

Ecole du Val-de-Grâce

Paris, 75005, France

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 16, 2020

Study Start

December 23, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

November 25, 2022

Record last verified: 2022-11

Locations