ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04431986
• Other study ID #: 2021-2432
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Jewish General Hospital
• Contact: Cyrille Launay, MD
• Phone: (+1) 514 340-8222
• Email: cyrille.launay[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1741
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Emergencies
• Frailty

Intervention

Other:
• No intervention: secondary use of a database
Statistical analyses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ER2	6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)	4 years
Primary	SOF index	index with 3 items determining a level of frailty from 0 (patient is vigorous) to 1 (patient is pre-frail)	4 years
Primary	CHS index	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
Primary	Rockwood index	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
Primary	Physical functional decline	annual variation of physical functional score available in the Nuage database	4 years
Primary	Falls	presence or absence of falls, information available in the Nuage database	4 years
Primary	Hospitalizations	presence or absence of hospitalizations, information available in the Nuage database	4 years
Primary	Mortality	death of the participant, information available in the Nuage database	4 years