NCT03962972

Brief 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 frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,741

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 23, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

May 23, 2019

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    the questionnaire will be used once, after 4 years follow-up.

Interventions

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).

Eligibility Criteria

Age67 Years - 82 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Healthy community-dwellers from Quebec, Canada * A follow-up during 4 years

You may qualify if:

  • Healthy community-dwellers from Quebec, Canada

You may not qualify if:

  • Community-dwellers from outside Quebec, Canada

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Chronic DiseaseFrailty

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Beauchet, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Geriatrics

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 24, 2019

Study Start

July 23, 2019

Primary Completion

December 15, 2021

Study Completion

January 1, 2025

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations