Old AgeNCT03978650
Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders
An observational study of Old Age and Fall Injury, run by Jewish General Hospital at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age, Fall Injury, Neurocognitive Disorders
- What is being tested?
- Observational
- How many people
- 12,000 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2019to 1 Jan 2026
- 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: * 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.
Who may be able to join
- People who are 65 years and over
- Men and women who live in Canada
Who cannot join
- People who do not live in Canada
- A fall resulting from acute medical event and/or an external factor
- Moderate to severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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).
- Conditions
- Old Age, Fall Injury, Neurocognitive Disorders
- Being tested
- Observational
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Participants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
Auditory verbal memory disorder
Investigator will use the Rey Auditory Verbal Test that evaluates the auditory-verbal memory.
Measured: around 20 years
The Mental Alteration Test
Investigator will evaluate the amnesia
Measured: around 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start23 Jul 2019
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies 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
- Prospective
- Enrolment
- 12,000 participants (estimated)
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
- NCT03978650
- Sponsor's protocol ID
- 2020-1804
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03978650
- Acronym / sponsor ID
- 2020-1804
- Conditions
- Old Age, Fall Injury, Neurocognitive Disorders
- 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
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Jun 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- People who are 65 years and over
- Men and women who live in Canada
Key exclusion criteria (3 listed)
- People who do not live in Canada
- A fall resulting from acute medical event and/or an external factor
- Moderate to severe dementia
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 |
|---|---|---|
| ObservationalParticipants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries. | Other | – |
Primary outcome
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.
2 secondary outcomes
Auditory verbal memory disorder
Time frame: around 20 years
The Mental Alteration Test
Time frame: around 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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 Old Age and Fall Injury, 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 3 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 23 Feb 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 Injury (time frame: 18 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 23 Feb 2024.