Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT04695457
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Identification of factors associated with the occurrence of COVID-19 outbreak in French Alps' nursing homes", 'timeFrame': 'day 1', 'description': '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.\n\nEvaluation, using a regression model, on aggregated data, of the associations (univariate, multivariate) between the occurrence of grouped cases and the following criteria:\n\n* Type of NH (public or private);\n* The average degree of dependency and of morbidity of the residents (Gir Moyen Pondéré (GMP) and Pathos Moyen pondéré (PMP)) scales.\n* Number of residents in the NH;\n* Human resources used during the epidemic:\n* Operational management of the crisis: date of visit ban, face mask\'s wearing condition for the personnel\n\nAssociations measured using "odds ratios" and their 95% confidence interval (95% CI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19', 'nursing home'], 'conditions': ['Covid19', 'Nursing Home']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nIn 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.\n\nTherefore 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "NH which are part of the French Alps in the ARA area.\n\nThe 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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hospital based NH in the French Alps\n* Non Hospital based NH in the French Alps\n* Study participation agreement from the NH's managers\n\nExclusion Criteria:\n\n* Refusal of the NH's managers to participate"}, 'identificationModule': {'nctId': 'NCT04695457', 'acronym': 'PROCOPAD', 'briefTitle': 'Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Annecy Genevois'}, 'officialTitle': 'Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps', 'orgStudyIdInfo': {'id': '20-13'}}, 'contactsLocationsModule': {'locations': [{'zip': '74394', 'city': 'Pringy', 'country': 'France', 'facility': 'Ch Annecy Genevois', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Annecy Genevois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}