Risk Factors for Falls and Neurocognitive Disorders CLSA

February 22, 2024 updated by: Olivier Beauchet, Jewish General Hospital

Risk Factors for Falls and Neurocognitive Disorders in the Older Canadian Population: A Population-based Cross-sectional Study

The study evaluates the association between the neurocognitive decline and falls.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals eligible for this study will be the participants of the CLSA

Description

Inclusion Criteria:

  • Age ≥ 65 and
  • 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).

Exclusion Criteria:

  • A fall resulting from acute medical events and/or external force,
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy / Non fallers
Older cognitively healthy individuals Non fallers
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
Healthy / Fallers without injuries
Older cognitively healthy individuals Fallers without injuries
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
Healthy / Fallers with injuries
Older cognitively healthy individuals Fallers with injuries
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
MCI / Non fallers
Older individuals with MCI and mild dementia Non fallers
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
MCI / Fallers without injury
Older individuals with MCI and mild dementia Fallers without injuries
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
MCI / Fallers with injury
Older individuals with MCI and mild dementia Fallers with injuries
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall-related injury
Time Frame: around 12 months
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.
around 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication
Time Frame: around 12 months
By using a questionnaire all participants will be ask to report the number of medications that they took the preceding month.
around 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olivier Beauchet, MD, Jewish General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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