Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps (PROCOPAD)

January 4, 2021 updated by: Centre Hospitalier Annecy Genevois
Since the beginning of the COVID-19 outbreak in France, nursing homes (NH) have been heavily affected. In this study, the investigators want to evaluate the factors associated with the occurrence of COVID-19 epidemic clusters within the nursing homes in the French Alps

Study Overview

Status

Completed

Conditions

Detailed Description

In France, between 1st of March and 29th of June 2020, the situation of NH was critical, with a total of 5,203 outbreaks (≥ 1case), of which 651 (13%) occurred in the Auvergne-Rhône-Alpes (ARA) area. In the ARA area, 3,885 residents of NH were confirmed cases (positiveness of the polymerase chain reaction (PCR) or of the serology testing), of which 1,772 (46%) subsequently died. To manage this crisis, the French government decided to first, ban the visits to residents and to reinforce hygiene measures targeting care workers, and secondly, of a national lock down. In the same time, shortage of personal protective equipment (PPE) had happened worldwide.

In this context, one can hypothesize that the occurrence of outbreaks and its spread among the residents of NH would have been initiated by the staff members. Nonetheless, the implementation of local actions might have been efficient to mitigate the epidemic, while on the other hand, shortage of PPE might have worsen the epidemic.

Therefore the investigators aimed to investigate the relationship between the occurrence of outbreak in residents and in staff members of nursing home, as well as the factors influencing this relationship, using data from a multicentric cross-sectional survey conducted in the French Alps, a part of ARA area.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pringy, France, 74394
        • CH Annecy Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NH which are part of the French Alps in the ARA area.

The questionnaire was made available on the internet 24 h/day, 7 days/week using the dedicated link sent to each NH through email by the research team on 15th of July. NH's managers had to respond to the survey.

Description

Inclusion Criteria:

  • Hospital based NH in the French Alps
  • Non Hospital based NH in the French Alps
  • Study participation agreement from the NH's managers

Exclusion Criteria:

  • Refusal of the NH's managers to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of factors associated with the occurrence of COVID-19 outbreak in French Alps' nursing homes
Time Frame: day 1

Establish the factors associated with the occurrence of clustered cases by comparing the structural and organizational characteristics of NHs having experienced grouped cases, that is to say having presented at least 3 cases of COVID-19 between March 01 and May 31, 2020 compared to NHs having no clustered cases of COVID-19 during this same period.

Evaluation, using a regression model, on aggregated data, of the associations (univariate, multivariate) between the occurrence of grouped cases and the following criteria:

  • Type of NH (public or private);
  • The average degree of dependency and of morbidity of the residents (Gir Moyen Pondéré (GMP) and Pathos Moyen pondéré (PMP)) scales.
  • Number of residents in the NH;
  • Human resources used during the epidemic:
  • Operational management of the crisis: date of visit ban, face mask's wearing condition for the personnel

Associations measured using "odds ratios" and their 95% confidence interval (95% CI).
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Annecy Genevois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2020

Primary Completion (ACTUAL)

November 16, 2020

Study Completion (ACTUAL)

November 16, 2020

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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