- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814161
FRailty Among Elderly Emergency Department Patients With Outcome Measures (FREEDOM)
April 12, 2022 updated by: National University Hospital, Singapore
Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS), Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F), which can potentially be adopted for daily practice in the busy ED.
It is timely as we projected that we will be seeing more elderly patients attending the ED for various medical and surgical conditions.
Their attendance at the ED would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 119085
- National University Hospital, Singapore
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly patients aged 65 years and above attending Emergency Department, National University Hospital, Singapore irrespective of reason for attendance and are planned for discharge from the Emergency Department.
Description
Inclusion Criteria:
- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.
Exclusion Criteria:
- Haemodynamically unstable patients
- Inability to obtain informed consent
- Inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers)
- Vulnerable populations (e.g. prisoners)
- Patients who are planned for hospital admission from the ED
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-month Adverse Event Occurrence (composite)
Time Frame: At 1 month after index ED visit
|
Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
|
At 1 month after index ED visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3-month Adverse Event Occurrence (composite)
Time Frame: At 3 months after index ED visit
|
Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
|
At 3 months after index ED visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ying Wei Yau, National University Hospital, Singapore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 20, 2019
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 12, 2018
First Submitted That Met QC Criteria
January 20, 2019
First Posted (Actual)
January 23, 2019
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FREEDOM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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