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

Covid19 Clinical Trial

— PROCOPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695457
• Other study ID #: 20-13
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Nursing Home

Locations

Country	Name	City	State
France	Ch Annecy Genevois	Pringy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of factors associated with the occurrence of COVID-19 outbreak in French Alps' nursing homes	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