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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03978650
Other study ID # 2020-1804
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 23, 2019
Est. completion date January 1, 2026

Study information

Verified date February 2024
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the risk for incident falls and fall-related injuries at the onset of neurocognitive disorders in older adults participating in the Canadian Longitudinal Study


Description:

Falls are frequent events in adults over age 65 (up to 30% each year in Canada). They are a major Canadian public health concern, which negatively impacts health and quality of life of fallers, and health care system. Neurocognitive disorders are strongly associated with falls and fall-related injuries. Several clinical characteristics, identified previously as risk factors for falls in the older population and in older adults with neurocognitive disorders are selected in the Canadian Longitudinal Study On Aging. The performance criteria of different statistical models will be compared for the association of neurocognitive disorders with falls and fall-related injuries. Six linear statistical models (i.e., logistic regression, discriminant analysis, Bayes network algorithm, decision tree, random forest, boosted trees), Factor Mixture Models and two different artificial neural network (i.e., multilayer perceptron and the neuroevolution of augmenting topologies).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12000
Est. completion date January 1, 2026
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - People who are 65 years and over - Men and women who live in Canada Exclusion Criteria: - People who do not live in Canada - A fall resulting from acute medical event and/or an external factor - Moderate to severe dementia

Study Design


Intervention

Other:
Observational
Participants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries.

Locations

Country Name City State
Canada Jewish General Hospital Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fall Injury Incident falls occurring during the 18 months. Information related fall- injuries will also be collected, including fractures, dislocations, voluminous intracranial or peripheral hematomas, trauma of the face, and cutaneous lacerations of significant size and/or deeper than the hypodermis, possibly resulting in medical consultation or hospitalization. 18 months
Secondary Auditory verbal memory disorder Investigator will use the Rey Auditory Verbal Test that evaluates the auditory-verbal memory. around 20 years
Secondary The Mental Alteration Test Investigator will evaluate the amnesia around 20 years
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