Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04782427
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Infections and Mortality in Long-term Care Facilities During the First Wave
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007239', 'term': '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1197}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '28 days', 'description': 'COVID-19 as a primary or secondary cause of death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Death', 'Infection Viral', 'Infections, Respiratory', 'Infection, Coronavirus', 'Elderly Infection', 'Old Age; Dementia', 'Epidemic Disease']}, 'descriptionModule': {'briefSummary': 'The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors.\n\nIndividual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).', 'detailedDescription': 'A lot has been written about individual risk factors for COVID-19 death, mostly in the hospitalized population. However, even though most deaths around the world have occurred among the frail and elderly, little is known about the risk factors specific to the long-term care population.\n\nIn this retrospective cohort study, the investigators will review the medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. The objective is to influence local and national policies in long-term care facilities, in the hopes of avoiding the tragic spring 2020 outcomes during subsequent waves of COVID-19 or future pandemics.\n\nCovariates in the models will be drawn from a review of the medical literature and known risk factors for COVID-19 death. Individual-level covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) as well as medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate-level covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Most of the residents living in the long-term care facilities are elderly and frail, with a high prevalence of major neurocognitive disorders and low life expectancy. However, some patients are more robust (e.g. residents of wandering wards) or younger (e.g. residents with heavy neurological or mental health diagnoses).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Resident of a long-term care facility within the CIUSSS Centre-Sud-de-l'Île-de-Montréal\n* Nosocomial COVID-19 infection diagnosis between March 23rd and July 11th 2020\n\nExclusion Criteria:\n\n* Admission to the long-term care facility after July 11th 2020\n* COVID-19 infection which was not acquired within the long-term care facility"}, 'identificationModule': {'nctId': 'NCT04782427', 'briefTitle': 'COVID-19 Infections and Mortality in Long-term Care Facilities During the First Wave', 'organization': {'class': 'OTHER_GOV', 'fullName': "Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal"}, 'officialTitle': 'COVID-19 Infections and Mortality in Montreal Long-term Care Facilities During the First Wave: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'CentreSuddeMontréal'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COVID-19 infection', 'type': 'OTHER', 'description': 'Case of nosocomial infection within the long-term care facility'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS Centre-Sud-de-l'Île-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Sophie Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'At the time of publication, for 5 years.', 'ipdSharing': 'YES', 'description': 'All deidentified information will be shared, except if there are patient confidentiality issues.', 'accessCriteria': 'Written request submitted to the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Université de Montréal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head physician of long-term care facilities and researcher', 'investigatorFullName': 'Sophie Zhang', 'investigatorAffiliation': "Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal"}}}}