Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT03628768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Falls and Neurocognitive Disorders CLSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fall-related injury', 'timeFrame': 'around 12 months', 'description': 'Fall-related injury is an event which results in a person coming to rest accidentally on the ground or floor. If participants report having had at least one injury during the past 12 month, they will be asked to answer additional questions that are related to the consequence of fall injury.'}], 'secondaryOutcomes': [{'measure': 'Medication', 'timeFrame': 'around 12 months', 'description': 'By using a questionnaire all participants will be ask to report the number of medications that they took the preceding month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurocognitive Disorders', 'Geriatrics']}, 'descriptionModule': {'briefSummary': 'The study evaluates the association between the neurocognitive decline and falls.', 'detailedDescription': "Falls in older adults are a major Canadian public health concern because: 1) They have a high prevalence and incidence (e.g., up to 30% each year in Canada, regardless the cognitive status of fallers), 2) They negatively impact an individual's health condition (e.g., hip fracture) and quality of life (e.g., social withdraw), and 3) They impose a high financial burden on the Canadian health care system (e.g., $2 billion per year). Major neurocognitive disorders are strongly associated with falls and their adverse outcomes. There is a greater risk for falls and fall-related injuries in cognitively impaired individuals, more than doubled compared to cognitively healthy individuals (CHI). The nature of the interactions between neurocognitive disorders and the other risk factors for falls and fall-related injuries are still a matter of debate. For instance, the presence of specific patterns (i.e., types and combinations) of risk factors for falls and fall-related injuries associated with neurocognitive disorders at their onset (i.e., mild cognitive impairment \\[MCI\\] and mild dementia) compared to CHI is questioned. Recently, the investigators howed that the identification of risk factors for falls is influenced by the method of data analysis used. The investigators demonstrated that emerging modeling techniques such as artificial neural networks (ANNs) improve the performance criteria of fall prediction compared to classical linear models. Other methods such as Factor Mixture Models (FMMs) may also be helpful in identification of patterns of risk factors for falls and fall-related injuries associated with neurocognitive disorders. Using baseline data from the Canadian Longitudinal Study on Aging (CLSA), the investigator will examine the patterns (i.e., types and combinations) of risk factors for falls and fall-related injuries associated with neurocognitive disorders at their onset by 1) Examining the epidemiology of falls and fall-related injuries, and 2) Modeling and comparing the associations of risk for falls and fall-related injuries between cognitively healthy and impaired (i.e., MCI and mild dementia) older adults participating in the CLSA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals eligible for this study will be the participants of the CLSA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 and\n* Participants of the Comprehensive CLSA (i.e., individuals who participated in a 90-minute in-home face-to-face interview, and a visit to one of 11 Data Collection Sites across Canada where they took part in a range of physical assessments).\n\nExclusion Criteria:\n\n* A fall resulting from acute medical events and/or external force,\n* Moderate to severe dementia (estimated from performance on cognitive tests and scores of the Activity of Daily Living (ADL) and Instrumental Activity Daily Living (IADL) scales. Abnormal scores will be defined as 2 Standard Deviations (SDs) or more below the normal score of all cognitive tests associated with scores of ADL (/6) \\<3 and a score of IADL (/8) \\<4)'}, 'identificationModule': {'nctId': 'NCT03628768', 'briefTitle': 'Risk Factors for Falls and Neurocognitive Disorders CLSA', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'Risk Factors for Falls and Neurocognitive Disorders in the Older Canadian Population: A Population-based Cross-sectional Study', 'orgStudyIdInfo': {'id': '2019-1453'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy / Non fallers', 'description': 'Older cognitively healthy individuals Non fallers', 'interventionNames': ['Other: Data collection']}, {'label': 'Healthy / Fallers without injuries', 'description': 'Older cognitively healthy individuals Fallers without injuries', 'interventionNames': ['Other: Data collection']}, {'label': 'Healthy / Fallers with injuries', 'description': 'Older cognitively healthy individuals Fallers with injuries', 'interventionNames': ['Other: Data collection']}, {'label': 'MCI / Non fallers', 'description': 'Older individuals with MCI and mild dementia Non fallers', 'interventionNames': ['Other: Data collection']}, {'label': 'MCI / Fallers without injury', 'description': 'Older individuals with MCI and mild dementia Fallers without injuries', 'interventionNames': ['Other: Data collection']}, {'label': 'MCI / Fallers with injury', 'description': 'Older individuals with MCI and mild dementia Fallers with injuries', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site', 'armGroupLabels': ['Healthy / Fallers with injuries', 'Healthy / Fallers without injuries', 'Healthy / Non fallers', 'MCI / Fallers with injury', 'MCI / Fallers without injury', 'MCI / Non fallers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Olivier Beauchet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Geriatrics', 'investigatorFullName': 'Olivier Beauchet', 'investigatorAffiliation': 'Jewish General Hospital'}}}}