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OpenTrials
Active, Not Recruiting

NCT Number: NCT03628768

Risk Factors for Falls and Neurocognitive Disorders CLSA

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Data Collection

Other

telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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