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

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.

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

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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