Neurocognitive DisordersNCT03628768
Risk Factors for Falls and Neurocognitive Disorders CLSA
An observational study of Neurocognitive Disorders and Geriatrics, run by Jewish General Hospital at 1 site in Canada.
Trial summary
The study evaluates the association between the neurocognitive decline and falls. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders, Geriatrics
- What is being tested?
- Data collection
- How many people
- 12,000 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2019to Feb 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Individuals eligible for this study will be the participants of the CLSA
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Falls and Neurocognitive Disorders in the Older Canadian Population: A Population-based Cross-sectional Study
The study evaluates the association between the neurocognitive decline and falls.
Read the detailed 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.
- Conditions
- Neurocognitive Disorders, Geriatrics
- Being tested
- Data collection
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
| Study group | Role | What they receive |
|---|---|---|
| Healthy / Non fallers | Older cognitively healthy individuals Non fallers Receives: Other: Data collection | |
| Healthy / Fallers without injuries | Older cognitively healthy individuals Fallers without injuries Receives: Other: Data collection | |
| Healthy / Fallers with injuries | Older cognitively healthy individuals Fallers with injuries Receives: Other: Data collection | |
| MCI / Non fallers | Older individuals with MCI and mild dementia Non fallers Receives: Other: Data collection | |
| MCI / Fallers without injury | Older individuals with MCI and mild dementia Fallers without injuries Receives: Other: Data collection | |
| MCI / Fallers with injury | Older individuals with MCI and mild dementia Fallers with injuries Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: around 12 months
Secondary outcomes (1)
Medication
By using a questionnaire all participants will be ask to report the number of medications that they took the preceding month.
Measured: around 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start23 Jul 2019
- Primary completionJul 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628768
- Sponsor's protocol ID
- 2019-1453
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Falls and Neurocognitive Disorders in the Older Canadian Population: A Population-based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03628768
- Acronym / sponsor ID
- 2019-1453
- Conditions
- Neurocognitive Disorders, Geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the association between the neurocognitive decline and falls.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy / Non fallers | – | Other: Data collectionOlder cognitively healthy individuals Non fallers |
| Healthy / Fallers without injuries | – | Other: Data collectionOlder cognitively healthy individuals Fallers without injuries |
| Healthy / Fallers with injuries | – | Other: Data collectionOlder cognitively healthy individuals Fallers with injuries |
| MCI / Non fallers | – | Other: Data collectionOlder individuals with MCI and mild dementia Non fallers |
| MCI / Fallers without injury | – | Other: Data collectionOlder individuals with MCI and mild dementia Fallers without injuries |
| MCI / Fallers with injury | – | Other: Data collectionOlder individuals with MCI and mild dementia Fallers with injuries |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Individuals eligible for this study will be the participants of the CLSA
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectiontelephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site | Other | Healthy / Fallers with injuries, Healthy / Fallers without injuries, Healthy / Non fallers, MCI / Fallers with injury, MCI / Fallers without injury, MCI / Non fallers |
Primary outcome
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.
1 secondary outcome
Medication
Time frame: around 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Neurocognitive Disorders
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Beauchet, MD principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders and Geriatrics, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall-related injury (time frame: around 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.