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出境医 / 临床实验 / Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders

Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders

Study Description
Brief 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

Condition or disease Intervention/treatment
Old Age Fall Injury Neurocognitive Disorders Other: Observational

Detailed 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).

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders in the Older Canadian Population: A Population-based, Prospective, Longitudinal, Observational Cohort Study
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : January 1, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Fall Injury [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Auditory verbal memory disorder [ Time Frame: around 20 years ]
    Investigator will use the Rey Auditory Verbal Test that evaluates the auditory-verbal memory.

  2. The Mental Alteration Test [ Time Frame: around 20 years ]
    Investigator will evaluate the amnesia


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 4, 2019
First Posted Date June 7, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date July 23, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019) 		Fall Injury [ Time Frame: 18 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • Auditory verbal memory disorder [ Time Frame: around 20 years ]
    Investigator will use the Rey Auditory Verbal Test that evaluates the auditory-verbal memory.
  • The Mental Alteration Test [ Time Frame: around 20 years ]
    Investigator will evaluate the amnesia
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders
Official Title Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders in the Older Canadian Population: A Population-based, Prospective, Longitudinal, Observational Cohort Study
Brief 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
Detailed 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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • People from Canada who are 65 years and over.
  • Men and women who were enrolled into the Canadian Longitudinal Study on Aging
  • Participants who attended the face-to-face interview questionnaires about diet, medication use, chronic disease symptoms, and sleep disorders.
Condition
  • Old Age
  • Fall Injury
  • Neurocognitive Disorders
Intervention Other: Observational
Participants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 6, 2019) 		12000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03978650
Other Study ID Numbers 2020-1804
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Olivier Beauchet, Jewish General Hospital
Study Sponsor Jewish General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Olivier Beauchet, MD Jewish General Hospital
PRS Account Jewish General Hospital
Verification Date July 2020

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