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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03628768
Other study ID # 2019-1453
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 23, 2019
Est. completion date February 2025

Study information

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

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12000
Est. completion date February 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

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-related injury 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 Medication By using a questionnaire all participants will be ask to report the number of medications that they took the preceding month. around 12 months
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