- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03628768
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
Conditions
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.
Sponsor
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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