NCT04780113

Brief Summary

Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 25, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

March 1, 2021

Last Update Submit

April 21, 2022

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Evolution of perceived stress during the epidemic wave of COVID19 vs. at the end of the epidemic wave of COVID19

    The perceived stress will be evaluated using the Perceived Stress Scale. This scale contains 10 items, with scores ranging from 0 to 40, with higher scores meaning a higher level of stress.

    maximum 6 months, according to the evolution of the epidemic

Secondary Outcomes (2)

  • Description of general characteristics of residents and their feelings and experiences with the sanitary crisis

    maximum 6 months, according to the evolution of the epidemic

  • Assessment of residents' profile stress according to their socio-demographic and working characteristics

    maximum 6 months, according to the evolution of the epidemic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants being general practice residents in Caen or Rouen

You may qualify if:

  • Being a general practice resident in Rouen or Caen
  • Participant informed and non-objection of him/her

You may not qualify if:

  • Being on maternity leave or not working during the period concerned with the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Eure-Seine

Évreux, 27015, France

Location

Study Officials

  • Ségolène Guillemette, MD

    General Practice Physician

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 3, 2021

Study Start

February 25, 2021

Primary Completion

September 24, 2021

Study Completion

September 24, 2021

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations

FR(1)