Covid19REMPAR-EHPADNCT04579289
Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions
An observational study of Covid19, run by Rennes University Hospital at 1 site in France.
Trial summary
REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- questionnaire
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 1 Sep 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Long Term Care Institution (EHPAD) director
Who may be able to join
- Long Term Care Institution (EHPAD) in Britain, France,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19
REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).
Read the detailed description
- Declarative retrospective survey : A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
- morbidity and mortality linked with COVID-19
- structural features of the facility (location, architecture, residents characteristics)
- human resources
- crisis management (visits and circulation restrictions, personal protective equipment) A statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one COVID 19 infection among the residents.
- Qualitative survey :
The investigators conducted semi-directed face-to-face interviews with facility directors. The investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). The interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.
- Conditions
- Covid19
- Being tested
- questionnaire
- Keywords
- Covid19, Elderly, Long term care, Crisis Management, France
- 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
A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
- morbidity and mortality linked with COVID-19
- structural features of the facility (location, architecture, residents characteristics)
- human resources
- crisis management (visits and circulation restrictions, personal protective equipment)
What is being measured
The primary outcome is the main question the study is designed to answer.
case of COVID 19
Number of case (confirmed or probable) of COVID 19 in each facility
Measured: 01 september 2020, survey closing date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Jun 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline MD CORVOL, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579289
- Sponsor's protocol ID
- 35RC20_8898_REMPAR-EHPAD
- Acronym
- REMPAR-EHPAD
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 14 Oct 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19
- ClinicalTrials.gov ID
- NCT04579289
- Acronym / sponsor ID
- REMPAR-EHPAD / 35RC20_8898_REMPAR-EHPAD
- Conditions
- Covid19
- Keywords
- Covid19, Elderly, Long term care, Crisis Management, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 8 Oct 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.
REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).
Detailed description
- Declarative retrospective survey : A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
- morbidity and mortality linked with COVID-19
- structural features of the facility (location, architecture, residents characteristics)
- human resources
- crisis management (visits and circulation restrictions, personal protective equipment) A statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one COVID 19 infection among the residents.
- Qualitative survey :
The investigators conducted semi-directed face-to-face interviews with facility directors. The investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). The interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Long Term Care Institution (EHPAD) director
Key inclusion criteria (1 listed)
- Long Term Care Institution (EHPAD) in Britain, France,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| questionnaireA questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning : * morbidity and mortality linked with COVID-19 * structural features of the facility (location, architecture, residents characteristics) * human resources * crisis management (visits and circulation restrictions, personal protective equipment) | Other | – |
Primary outcome
case of COVID 19
Time frame: 01 september 2020, survey closing date
Number of case (confirmed or probable) of COVID 19 in each facility
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 14 Oct 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.
Aline MD CORVOL principal investigator
Rennes University Hospital
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 Covid19, run by Rennes University Hospital 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 1 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 14 Oct 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?
case of COVID 19 (time frame: 01 september 2020, survey closing date). 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 14 Oct 2020.