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

Sponsor
Centre Hospitalier Annecy Genevois (Other)
Overall Status
Completed
CT.gov ID
NCT04695457
Collaborator
(none)
74
1
4.1
18.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps
    Actual Study Start Date :
    Jul 15, 2020
    Actual Primary Completion Date :
    Nov 16, 2020
    Actual Study Completion Date :
    Nov 16, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Identification of factors associated with the occurrence of COVID-19 outbreak in French Alps' nursing homes [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ch Annecy Genevois Pringy France 74394

    Sponsors and Collaborators

    • Centre Hospitalier Annecy Genevois

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Annecy Genevois
    ClinicalTrials.gov Identifier:
    NCT04695457
    Other Study ID Numbers:
    • 20-13
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Annecy Genevois
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2021