CovIdeDocS: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

• Sponsor: Direction Centrale du Service de Santé des Armées (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04667962
• Collaborator: (none)
• Enrollment: 302
• Locations: 2
• Anticipated Duration (Months): 8.3
• Patients Per Site: 151
• Patients Per Site Per Month: 18.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burnout, Caregiver	Other: Online questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 302 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain
• Actual Study Start Date: Dec 23, 2020
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Hospital service change This group is composed of caregivers who changed hospital service during COVID-19 health crisis.	Other: Online questionnaire; 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.
No hospital service change This group is composed of caregivers who have not changed hospital service during COVID-19 health crisis.	Other: Online questionnaire; 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• To be caregivers

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Recherche Biomédicale des Armées	Brétigny-sur-Orge		France	91223
2	Ecole du Val-de-Grâce	Paris		France	75005

Sponsors and Collaborators

• Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Direction Centrale du Service de Santé des Armées
• ClinicalTrials.gov Identifier: NCT04667962
• Other Study ID Numbers: 2020-COVID19-33; 2020-A02932-37
• First Posted: Dec 16, 2020
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Caregiver Burden

Study Results

No Results Posted as of Mar 9, 2021