NCT03628768

Brief Summary

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5.9 years

First QC Date

August 9, 2018

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Medication

    around 12 months

Study Arms (6)

Healthy / Non fallers

Older cognitively healthy individuals Non fallers

Other: Data collection

Healthy / Fallers without injuries

Older cognitively healthy individuals Fallers without injuries

Other: Data collection

Healthy / Fallers with injuries

Older cognitively healthy individuals Fallers with injuries

Other: Data collection

MCI / Non fallers

Older individuals with MCI and mild dementia Non fallers

Other: Data collection

MCI / Fallers without injury

Older individuals with MCI and mild dementia Fallers without injuries

Other: Data collection

MCI / Fallers with injury

Older individuals with MCI and mild dementia Fallers with injuries

Other: Data collection

Interventions

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

Healthy / Fallers with injuriesHealthy / Fallers without injuriesHealthy / Non fallersMCI / Fallers with injuryMCI / Fallers without injuryMCI / Non fallers

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals eligible for this study will be the participants of the CLSA

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

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

Data Collection

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Olivier Beauchet, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

July 23, 2019

Primary Completion

July 1, 2025

Study Completion

February 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations