NCT04695457

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 8, 2020

Last Update Submit

January 4, 2021

Conditions

Keywords

covid19nursing home

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Refusal of the NH's managers to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Annecy Genevois

Pringy, 74394, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

January 5, 2021

Study Start

July 15, 2020

Primary Completion

November 16, 2020

Study Completion

November 16, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations