PsychologicalResi-CoVNCT04349163
Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period : Prospective Cohort.
An observational study of Psychological, run by University Hospital, Angers at 1 site in France.
Trial summary
The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological
- What is being tested?
- Questionnaire
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2020to 25 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All caregivers willing to answer.
Who may be able to join
- Caregivers (physicians, nurses)
- working in the Emergency Department, Anaesthesiology, Infectious Department, Intensive care Unit.
- Voluntary to answer the questionnaire
Who cannot join
- Working in another Department
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period
The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.
Read the detailed description
Caregivers will be invited to complete a self-administered questionnaire online via a personalized electronic message. Caregivers will be free to participate. Signed consent will not be requested, but the return of the questionnaire will be considered consent. The questionnaire will be administered using Google form® software. Caregivers will have 2 weeks to respond. A reminder will be made at 7 days. The questionnaire will be anonymized upon receipt by the investigator.
- Conditions
- Psychological
- Being tested
- Questionnaire
- Keywords
- caregivers, covid-19, resilience, questionnaire, CD-RISC 25
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
CD-RISC 25 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Physicians and nurses working at the Emergency Department, Intensive care Unit, infectious disease Department, Anaesthesiology. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the level of resilience between physicians and caregivers of different specialties and in different workplaces according to the covid-19 epidemic.
CD-RISC-25 : Connor-Davidson Resilience Scale - 25. This scale contain 25 questions each range from 1 to 5. The total is 100 points which means a very high level of resilience.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start10 May 2020
- Primary completion15 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Delphine Douillet, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349163
- Sponsor's protocol ID
- 2020-A00831-39
- Acronym
- Resi-CoV
- Status last verified
- May 2020
- First submitted
- 13 Apr 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Evaluation of Caregivers During the SARS-CoV2 Epidemic Period
- ClinicalTrials.gov ID
- NCT04349163
- Acronym / sponsor ID
- Resi-CoV / 2020-A00831-39
- Conditions
- Psychological
- Keywords
- caregivers, covid-19, resilience, questionnaire, CD-RISC 25
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 May 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The outbreak linked to SARS-CoV-2 infection was declared a Public Health Emergency of International Concern on 30 January 2020. In all of the emergency Departments, a major reorganization was necessary, notably with the creation of a specific channel for COVID-19 suspect patients. Thus, all caregivers involved must adapt day by day to new places of exercise, new protocols,...The major influx of patients, the precautions to be taken, the specifics of the pathology and its management have profoundly changed daily practice. This exogenous hospital tension impacts all caregivers and more particularly their resilience capacities. Resilience is defined as an ability to recover from or adjust easily to misfortune or change. The Resi-CoV study aims to assess the level of resilience of caregivers of different specialties and trades in the context of covid-19.
Detailed description
Caregivers will be invited to complete a self-administered questionnaire online via a personalized electronic message. Caregivers will be free to participate. Signed consent will not be requested, but the return of the questionnaire will be considered consent. The questionnaire will be administered using Google form® software. Caregivers will have 2 weeks to respond. A reminder will be made at 7 days. The questionnaire will be anonymized upon receipt by the investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: QuestionnairePhysicians and nurses working at the Emergency Department, Intensive care Unit, infectious disease Department, Anaesthesiology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All caregivers willing to answer.
Key inclusion criteria (3 listed)
- Caregivers (physicians, nurses)
- working in the Emergency Department, Anaesthesiology, Infectious Department, Intensive care Unit.
- Voluntary to answer the questionnaire
Key exclusion criteria (1 listed)
- Working in another Department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireCD-RISC 25 questionnaire | Other | Caregivers |
Primary outcome
compare the level of resilience between physicians and caregivers of different specialties and in different workplaces according to the covid-19 epidemic.
Time frame: 14 days
CD-RISC-25 : Connor-Davidson Resilience Scale - 25. This scale contain 25 questions each range from 1 to 5. The total is 100 points which means a very high level of resilience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine Douillet principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the level of resilience between physicians and caregivers of different specialties and in different workplaces according to the covid-19 epidemic. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.