NCT03978650

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

June 4, 2019

Last Update Submit

February 22, 2024

Conditions

Old AgeFall InjuryNeurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

  • Fall Injury

    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.

    18 months

Secondary Outcomes (2)

  • Auditory verbal memory disorder

    around 20 years

  • The Mental Alteration Test

    around 20 years

Interventions

ObservationalOTHER

Participants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • People who are 65 years and over
  • Men and women who live in Canada

You may not qualify if:

  • People who do not live in Canada
  • A fall resulting from acute medical event and/or an external factor
  • Moderate to severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Olivier Beauchet, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Geriatrics

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 7, 2019

Study Start

July 23, 2019

Primary Completion

August 1, 2025

Study Completion

January 1, 2026

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

CA(1)