- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431986
ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers
June 11, 2020 updated by: Cyrille Launay, Jewish General Hospital
Association Between Emergency Room Evaluation and Recommendations Tool (ER2) Frailty Levels and Incident Adverse Health Events in Older Community Dwellers: Results of the NuAge Study
Older adults' health and functional status are heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty 1-4.
Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of chronic diseases causing disability but not mortality 5. Health systems need to face this new challenge 4,5.
Quantification of frailty and its association with the occurrence of incident adverse health events (i.e., functional decline, unplanned hospitalizations) is crucial to understand how health systems may efficiently respond to this situation 6.
This study aims to examine the association of the ER2 tool score and its stratification in three levels for incident adverse health events in older community dwellers and to compare this association with three validity frailty indexes which are the Cardiovascular Health Study (CHS) frailty index, Study of Osteoporotic Fracture (SOF) index and Rockwood frailty index.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1741
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals eligible for this study will be participants of the NuAge study who agreed to be part of the NuAge Database and Biobank for future research purposes
Description
Inclusion Criteria:
- All enrolled participants of NuAge Study who agreed to be part of the NuAge Database and Biobank for future research purposes
Exclusion Criteria:
- Missing data
- Participants' refusal to use their data for a purpose not identified during their recruitment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NuAge participants
All Individuals of the NuAge study who agreed to be part of the NuAge Database for future research purposes
|
Statistical analyses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ER2
Time Frame: 4 years
|
6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)
|
4 years
|
SOF index
Time Frame: 4 years
|
index with 3 items determining a level of frailty from 0 (patient is vigorous) to 1 (patient is pre-frail)
|
4 years
|
CHS index
Time Frame: 4 years
|
index with 5 items determining a level of frailty from 0 component positive (patient is vigorous), 1 or 2 positive components (patient is in an intermediate stage) to 3 or more positive components (patients is frail)
|
4 years
|
Rockwood index
Time Frame: 4 years
|
index determining a level of frailty from 0 to 17 (less than 5: patient is vigorous, between 6 and 11 patient is apparently vulnerable and above 12 patient is in severe frailty)
|
4 years
|
Physical functional decline
Time Frame: 4 years
|
annual variation of physical functional score available in the Nuage database
|
4 years
|
Falls
Time Frame: 4 years
|
presence or absence of falls, information available in the Nuage database
|
4 years
|
Hospitalizations
Time Frame: 4 years
|
presence or absence of hospitalizations, information available in the Nuage database
|
4 years
|
Mortality
Time Frame: 4 years
|
death of the participant, information available in the Nuage database
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cyrille Launay, MD, Jewish General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 11, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2432
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The databank property is not ours.
We do not have the right to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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