FrailtyNCT03991806
Association of Centre of Excellence Self- Administered Questionnaire Score and Frailty Levels
An observational study of Frailty and Cognitive Decline, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This study evaluates the frailty and the health adverse events in the population of the Canadian Longitudinal Study on Aging. It will be used the Centre of Excellence Self-Administered questionnaire (CESAM) which assesses frailty of older adults by providing a score and a of frailty in 4 levels. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Cognitive Decline, Injuries
- What is being tested?
- Obsservational
- How many people
- 30,000 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2020to 31 Aug 2025
- 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: In this research study take part people that are enrolled in the Canadian Longitudinal Study on Aging. Moreover, they are community dwellers who are frequently exposed to different health adverse events.
Who may be able to join
- Being 65 years and over
- Being enrolled in the Canadian Longitudinal Study on Aging
Who cannot join
- Never being enrolled in the Canadian Longitudinal Study on Aging
- Undisclosed health adverse events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels With Incident Health Adverse Events in Older Community Dwellers: Results of the Canadian Longitudinal Study on Aging
This study evaluates the frailty and the health adverse events in the population of the Canadian Longitudinal Study on Aging. It will be used the Centre of Excellence Self-Administered questionnaire (CESAM) which assesses frailty of older adults by providing a score and a of frailty in 4 levels.
Read the detailed description
Age is broadly recognized to confer a risk for health adverse outcomes, but it is an insensitive and non-specific measure for use in individual decision-making. Frailty has been emerging to take its rightful place as a better measure for over past decades. Despite general consensus that the concept of frailty is clinically useful, the lack of agreement on its definition and the challenge of its measurement by front-line health providers mean that frailty remains only 'their apparent' to chronological age as a criterion to select older persons at risk.
- Conditions
- Frailty, Cognitive Decline, Injuries, Fall Injury
- Being tested
- Obsservational
- Medical subject headings
- Frailty, Cognitive Dysfunction, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObsservationalOther
The frailty and the health adverse events of older adults will be assessed by using a questionnaire called: Association of Centre of Excellence Self-Administered questionnaire (CESAM).
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia
The algorithm is a three- step process involving administration of the neuropsychological battery to develop composite score in the three domains-memory, executive function, and psychomotor speed.
The primary outcome of the study will be to determine the number of participants to whom the memory, the executive function, and the psychomotor speed are affected.
Measured: around 18 months
Secondary outcomes (1)
Medication
In the maintaining contact interview, one question will be asked of all participants in relation to prescription medication use in the preceding month. A second question asks about the frequency of prescription drug use during this month.
The secondary outcome of the study will be to determine the number of the medication that the participant take during a period of time.
Measured: around 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start31 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 30,000 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
- NCT03991806
- Sponsor's protocol ID
- 2020-1844
- Status last verified
- Feb 2024
- First submitted
- 14 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
- Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels With Incident Health Adverse Events in Older Community Dwellers: Results of the Canadian Longitudinal Study on Aging
- ClinicalTrials.gov ID
- NCT03991806
- Acronym / sponsor ID
- 2020-1844
- Conditions
- Frailty, Cognitive Decline, Injuries, Fall Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 31 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 19 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 frailty and the health adverse events in the population of the Canadian Longitudinal Study on Aging. It will be used the Centre of Excellence Self-Administered questionnaire (CESAM) which assesses frailty of older adults by providing a score and a of frailty in 4 levels.
Detailed description
Age is broadly recognized to confer a risk for health adverse outcomes, but it is an insensitive and non-specific measure for use in individual decision-making. Frailty has been emerging to take its rightful place as a better measure for over past decades. Despite general consensus that the concept of frailty is clinically useful, the lack of agreement on its definition and the challenge of its measurement by front-line health providers mean that frailty remains only 'their apparent' to chronological age as a criterion to select older persons at risk.
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
- In this research study take part people that are enrolled in the Canadian Longitudinal Study on Aging. Moreover, they are community dwellers who are frequently exposed to different health adverse events.
Key inclusion criteria (2 listed)
- Being 65 years and over
- Being enrolled in the Canadian Longitudinal Study on Aging
Key exclusion criteria (2 listed)
- Never being enrolled in the Canadian Longitudinal Study on Aging
- Undisclosed health adverse events
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 |
|---|---|---|
| ObsservationalThe frailty and the health adverse events of older adults will be assessed by using a questionnaire called: Association of Centre of Excellence Self-Administered questionnaire (CESAM). | Other | – |
Primary outcome
Dementia
Time frame: around 18 months
The algorithm is a three- step process involving administration of the neuropsychological battery to develop composite score in the three domains-memory, executive function, and psychomotor speed. The primary outcome of the study will be to determine the number of participants to whom the memory, the executive function, and the psychomotor speed are affected.
1 secondary outcome
Medication
Time frame: around 18 months
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 Frailty and Cognitive Decline, 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 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?
Dementia (time frame: around 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.