FrailtyNCT04431986
ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers
An observational study of Frailty and Emergencies, run by Jewish General Hospital.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Frailty, Emergencies, Aging
- How many people
- 1,741 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- All enrolled participants of NuAge Study who agreed to be part of the NuAge Database and Biobank for future research purposes
Who cannot join
- Missing data
- Participants' refusal to use their data for a purpose not identified during their recruitment.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Frailty, Emergencies, Aging
- Being tested
- No intervention: secondary use of a database
- Medical subject headings
- Frailty, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention: secondary use of a databaseOther
Statistical analyses
| Study group | Role | What they receive |
|---|---|---|
| NuAge participants | All Individuals of the NuAge study who agreed to be part of the NuAge Database for future research purposes Receives: Other: No intervention: secondary use of a database |
What is being measured
The primary outcome is the main question the study is designed to answer.
ER2
6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)
Measured: 4 years
SOF index
index with 3 items determining a level of frailty from 0 (patient is vigorous) to 1 (patient is pre-frail)
Measured: 4 years
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)
Measured: 4 years
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)
Measured: 4 years
Physical functional decline
annual variation of physical functional score available in the Nuage database
Measured: 4 years
Falls
presence or absence of falls, information available in the Nuage database
Measured: 4 years
Hospitalizations
presence or absence of hospitalizations, information available in the Nuage database
Measured: 4 years
Mortality
death of the participant, information available in the Nuage database
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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, Cyrille Launay, Jewish General Hospital
- Investigators
- Cyrille Launay, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431986
- Sponsor's protocol ID
- 2021-2432
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The databank property is not ours. We do not have the right to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04431986
- Acronym / sponsor ID
- 2021-2432
- Conditions
- Frailty, Emergencies, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,741 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 16 Jun 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuAge participants | – | Other: No intervention: secondary use of a databaseAll Individuals of the NuAge study who agreed to be part of the NuAge Database for future research purposes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All enrolled participants of NuAge Study who agreed to be part of the NuAge Database and Biobank for future research purposes
Key exclusion criteria (2 listed)
- Missing data
- Participants' refusal to use their data for a purpose not identified during their recruitment.
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 |
|---|---|---|
| No intervention: secondary use of a databaseStatistical analyses | Other | NuAge participants |
Primary outcome
ER2
Time frame: 4 years
6-item questionnaire determining a stratification of frailty risk in three levels (Low, moderate, high)
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)
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)
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)
Physical functional decline
Time frame: 4 years
annual variation of physical functional score available in the Nuage database
Falls
Time frame: 4 years
presence or absence of falls, information available in the Nuage database
Hospitalizations
Time frame: 4 years
presence or absence of hospitalizations, information available in the Nuage database
Mortality
Time frame: 4 years
death of the participant, information available in the Nuage database
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No. The databank property is not ours. We do not have the right to share IPD.
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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.
Cyrille Launay, MD principal investigator
Jewish General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Emergencies, run by Jewish General Hospital.
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 2 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Cyrille Launay, MD ((+1) 514 340-8222 ext. 23837, cyrille.launay@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ER2 (time frame: 4 years). The study lists 8 primary outcomes in all. 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 16 Jun 2020.