Chronic DiseaseNCT03962972
Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels
An observational study of Chronic Disease and Frailty, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This study evaluates the association of the Self-Administered questionnaire (CESAM) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the Cardiovascular Health Study… Read more about this study
- Who is it for?
- Ages 67 to 82 years
- Conditions the study is for
- Chronic Disease, Frailty, Disability Physical
- What is being tested?
- Frailty evaluation
- How many people
- 1,741 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jul 2019to 1 Jan 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 67 to 82 years
- All sexes
- Older adult
Study population: * Healthy community-dwellers from Quebec, Canada * A follow-up during 4 years
Who may be able to join
- -Healthy community-dwellers from Quebec, Canada
Who cannot join
- -Community-dwellers from outside Quebec, Canada
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 Adverse Health Events in Older Community Dwellers: Results of the NuAge Study
This study evaluates the association of the Self-Administered questionnaire (CESAM) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.
Read the detailed description
Older adults' health and functional status is heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty. Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of disorders causing disability but not mortality. Health systems thus need to face this new challenge. Quantification of frailty and its association with the occurrence of adverse health events is crucial to understand how efficiently health systems may respond to this situation.
This study aims to examine the association of the CESAM score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with a) five validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index, Rockwood frailty index, 6-item brief geriatric assessment (BGA) and "Program of Research on the Integration of Services for the Maintenance of Autonomy" (PRISMA-7) and b) two new frailty indexes developed over the COVID-19 pandemic which are "Évaluation SOcio-GÉriatrique" (ESOGER) and "CriblAge et REcommandations" (CARE).
- Conditions
- Chronic Disease, Frailty, Disability Physical
- Being tested
- Frailty evaluation
- Medical subject headings
- Chronic Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty evaluationOther
It will be used a questionnaire that is called:The Centre of Excellence Self-Administered questionnaire (CESAM). The score of this questionnaire and its stratification of frailty in four levels with incident adverse health events in older community dwellers will be compare with validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index, Rockwood frailty index, 6-ietm brief geriatric assessment (BGA), "Program of Research on the Integration of Services for the Maintenance of Autonomy" (PRISMA-7) and b) two other frailty index developed over the COVID-19 pandemic which are "Évaluation SOcio-GÉriatrique" (ESOGER) and "CriblAge et REcommandations" (CARE).
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
It will be used a questionnaire called:The Centre of Excellence Self-Administered questionnaire(CESAM). This questionnaire evaluates frailty of older adults by providing a score and a stratification of frailty in 4 levels (Vigorous versus mild, moderate and severe frailty).
Measured: the questionnaire will be used once, after 4 years follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start23 Jul 2019
- Primary completion15 Dec 2021
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- 1,741 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
- NCT03962972
- Sponsor's protocol ID
- 2020-1793
- Status last verified
- Apr 2024
- First submitted
- 23 May 2019
- Last updated
- 5 Apr 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 5 Apr 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 Adverse Health Events in Older Community Dwellers: Results of the NuAge Study
- ClinicalTrials.gov ID
- NCT03962972
- Acronym / sponsor ID
- 2020-1793
- Conditions
- Chronic Disease, Frailty, Disability Physical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,741 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 May 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 association of the Self-Administered questionnaire (CESAM) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.
Detailed description
Older adults' health and functional status is heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty. Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of disorders causing disability but not mortality. Health systems thus need to face this new challenge. Quantification of frailty and its association with the occurrence of adverse health events is crucial to understand how efficiently health systems may respond to this situation.
This study aims to examine the association of the CESAM score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with a) five validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index, Rockwood frailty index, 6-item brief geriatric assessment (BGA) and "Program of Research on the Integration of Services for the Maintenance of Autonomy" (PRISMA-7) and b) two new frailty indexes developed over the COVID-19 pandemic which are "Évaluation SOcio-GÉriatrique" (ESOGER) and "CriblAge et REcommandations" (CARE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 67 to 82 years
- Sex
- All
- Age groups
- Older adult
- Study population
- * Healthy community-dwellers from Quebec, Canada * A follow-up during 4 years
Key inclusion criteria (1 listed)
- -Healthy community-dwellers from Quebec, Canada
Key exclusion criteria (1 listed)
- -Community-dwellers from outside Quebec, Canada
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 |
|---|---|---|
| Frailty evaluationIt will be used a questionnaire that is called:The Centre of Excellence Self-Administered questionnaire (CESAM). The score of this questionnaire and its stratification of frailty in four levels with incident adverse health events in older community dwellers will be compare with validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index, Rockwood frailty index, 6-ietm brief geriatric assessment (BGA), "Program of Research on the Integration of Services for the Maintenance of Autonomy" (PRISMA-7) and b) two other frailty index developed over the COVID-19 pandemic which are "Évaluation SOcio-GÉriatrique" (ESOGER) and "CriblAge et REcommandations" (CARE). | Other | – |
Primary outcome
Frailty
Time frame: the questionnaire will be used once, after 4 years follow-up.
It will be used a questionnaire called:The Centre of Excellence Self-Administered questionnaire(CESAM). This questionnaire evaluates frailty of older adults by providing a score and a stratification of frailty in 4 levels (Vigorous versus mild, moderate and severe frailty).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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 Chronic Disease and Frailty, 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 1 inclusion and 1 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 5 Apr 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?
Frailty (time frame: the questionnaire will be used once, after 4 years follow-up.). 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 5 Apr 2024.