Geriatric, Frailty, Emergency DepartmentFREEDOMNCT03814161
FRailty Among Elderly Emergency Department Patients With Outcome Measures
An observational study of Geriatric, Frailty, Emergency Department, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric, Frailty, Emergency Department
- How many people
- 211 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jan 2019to 1 Dec 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Geriatric, Frailty, Emergency Department
- Medical subject headings
- Frailty, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
1-month Adverse Event Occurrence (composite)
Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
Measured: At 1 month after index ED visit
Secondary outcomes (1)
3-month Adverse Event Occurrence (composite)
Falls, ED re-attendance, hospital/ nursing home admission, decline in Activities of Daily Living and/or all-cause mortality
Measured: At 3 months after index ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start20 Jan 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric, Frailty, Emergency DepartmentStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Wei Yau, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814161
- Sponsor's protocol ID
- FREEDOM
- Acronym
- FREEDOM
- Status last verified
- Mar 2022
- First submitted
- 12 Oct 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
PubMed 23764209
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRailty Among Elderly Emergency Department Patients With Outcome Measures
- ClinicalTrials.gov ID
- NCT03814161
- Acronym / sponsor ID
- FREEDOM / FREEDOM
- Conditions
- Geriatric, Frailty, Emergency Department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 211 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Jan 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
3-month Adverse Event Occurrence (composite)
Time frame: At 3 months after index ED visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 23764209Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
- Individual participant dataSharing planned: No
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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.
Ying Wei Yau principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric, Frailty, Emergency Department, run by National University Hospital, Singapore at 1 site in Singapore.
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 5 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-month Adverse Event Occurrence (composite) (time frame: At 1 month after index ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814161, which also lists 1 linked publication.
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 20 Apr 2022.