FallFALL-ADLNCT07163715
Incidence and Factors of Functional Decline After Emergency Department Discharge in Older Adults With Falls
An observational study of Fall and Daily Activities, run by Ege University.
Trial summary
The goal of this observational study is to learn about changes in activities of daily living (ADL) in older adults after being discharged from the emergency department (ED) following a fall. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fall, Daily Activities, Functional Decline
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2025to 5 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Older adult
Study population: The study population will consist of community-dwelling older adults aged 65 years and older who present to the emergency department (ED) with a simple fall and are discharged without hospitalization. Participants must be cognitively able to complete baseline and follow-up assessments. This population represents a group at risk of functional decline despite not requiring inpatient admission. By focusing on older adults discharged from the ED, the study aims to capture real-world outcomes in a population that is often underrepresented in research but commonly experiences falls and subsequent declines in independence.
Who may be able to join
- Age ≥ 65 years
- Presentation to the emergency department with a simple (non-injurious) fall
- Discharged from the ED without hospitalization
- Cognitively able to answer online or telephone follow-up interviews
Who cannot join
- Falls due to traumatic events other than simple falls
- Hospital admission required after the fall
- Presence of acute confusion, dementia, or other severe cognitive impairment
- Inability to access online or telephone follow-up during the 30-day study period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Şadiye Mıdık contact
About this study
Official title: Prospective Cohort Study on the Incidence and Associated Factors of Decline in Activities of Daily Living Among Older Adults Discharged From the Emergency Department After a Fall
The goal of this observational study is to learn about changes in activities of daily living (ADL) in older adults after being discharged from the emergency department (ED) following a fall.
The main questions this study aims to answer are:
Read more
How often do older adults experience a decline in their ability to perform daily activities after being discharged from the ED for a fall? What health or lifestyle factors (such as frailty, medications, physical activity, or fear of falling) are related to this decline? Participants will be 65 years or older, admitted to the ED for a simple fall, and discharged without hospitalization. At the time of their ED visit, participants will be asked questions about their health, medications, activity level, and daily functioning. They will then be contacted online or by phone at 7 days and 30 days after discharge to answer follow-up questions.
This study will help identify how common functional decline is after falls in older adults discharged from the ED, and which factors may predict higher risk. These findings could help improve follow-up care and prevention strategies for older patients.
Read the detailed description
Falls are one of the leading causes of morbidity and functional decline in older adults. Even in cases without major injury requiring hospitalization, falls can lead to decreased independence and reduced quality of life. Functional decline, often measured as deterioration in activities of daily living (ADL), is associated with frailty, multimorbidity, polypharmacy, fear of falling, and reduced physical activity. Early identification of older patients at risk for functional decline after an emergency department (ED) visit is critical for designing timely interventions and improving patient outcomes.
This prospective cohort study will enroll 280 patients aged 65 years and older who present to the ED with a simple fall and are discharged without hospitalization. Baseline data will be collected at the time of ED visit, including demographic characteristics, comorbidities, medication use, frailty status (Clinical Frailty Scale), physical activity level (Physical Activity Scale for the Elderly, PASE), fall risk (MEFRAT), and fear of falling (Falls Efficacy Scale-International, FES-I). ADL status will be assessed at baseline and re-assessed at 7 and 30 days after discharge through online or telephone interviews.
The primary outcome is the incidence of decline in ADL within 30 days after ED discharge. Secondary analyses will examine associations between demographic, clinical, functional, and psychosocial factors and the risk of ADL decline, using logistic regression models.
The study is expected to provide valuable insights into the frequency and determinants of functional decline among older adults after ED discharge for falls. Identifying these risk factors will inform strategies for early recognition, follow-up care, and targeted interventions aimed at preventing functional decline and maintaining independence in older patients.
- Keywords
- Falls, Decline fictional status, Decline daily activities, Emergency medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in Activities of Daily Living
Change in Activities of Daily Living (ADL) score from baseline to follow-up. Decline is defined as an increase in dependency in at least one ADL item compared with baseline.
Measured: Baseline (ED discharge), 7 days, and 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completion5 Nov 2025 (estimated)
- Study completion5 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozge Can. MD, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163715
- Sponsor's protocol ID
- 25-8T/108
- Acronym
- FALL-ADL
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Incidence and Associated Factors of Decline in Activities of Daily Living Among Older Adults Discharged From the Emergency Department After a Fall
- ClinicalTrials.gov ID
- NCT07163715
- Acronym / sponsor ID
- FALL-ADL / 25-8T/108
- Keywords
- Falls, Decline fictional status, Decline daily activities, Emergency medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 5 Dec 2025 (estimated)
- First posted
- 9 Sep 2025 (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.
The goal of this observational study is to learn about changes in activities of daily living (ADL) in older adults after being discharged from the emergency department (ED) following a fall.
The main questions this study aims to answer are:
How often do older adults experience a decline in their ability to perform daily activities after being discharged from the ED for a fall? What health or lifestyle factors (such as frailty, medications, physical activity, or fear of falling) are related to this decline? Participants will be 65 years or older, admitted to the ED for a simple fall, and discharged without hospitalization. At the time of their ED visit, participants will be asked questions about their health, medications, activity level, and daily functioning. They will then be contacted online or by phone at 7 days and 30 days after discharge to answer follow-up questions.
This study will help identify how common functional decline is after falls in older adults discharged from the ED, and which factors may predict higher risk. These findings could help improve follow-up care and prevention strategies for older patients.
Detailed description
Falls are one of the leading causes of morbidity and functional decline in older adults. Even in cases without major injury requiring hospitalization, falls can lead to decreased independence and reduced quality of life. Functional decline, often measured as deterioration in activities of daily living (ADL), is associated with frailty, multimorbidity, polypharmacy, fear of falling, and reduced physical activity. Early identification of older patients at risk for functional decline after an emergency department (ED) visit is critical for designing timely interventions and improving patient outcomes.
This prospective cohort study will enroll 280 patients aged 65 years and older who present to the ED with a simple fall and are discharged without hospitalization. Baseline data will be collected at the time of ED visit, including demographic characteristics, comorbidities, medication use, frailty status (Clinical Frailty Scale), physical activity level (Physical Activity Scale for the Elderly, PASE), fall risk (MEFRAT), and fear of falling (Falls Efficacy Scale-International, FES-I). ADL status will be assessed at baseline and re-assessed at 7 and 30 days after discharge through online or telephone interviews.
The primary outcome is the incidence of decline in ADL within 30 days after ED discharge. Secondary analyses will examine associations between demographic, clinical, functional, and psychosocial factors and the risk of ADL decline, using logistic regression models.
The study is expected to provide valuable insights into the frequency and determinants of functional decline among older adults after ED discharge for falls. Identifying these risk factors will inform strategies for early recognition, follow-up care, and targeted interventions aimed at preventing functional decline and maintaining independence in older patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- The study population will consist of community-dwelling older adults aged 65 years and older who present to the emergency department (ED) with a simple fall and are discharged without hospitalization. Participants must be cognitively able to complete baseline and follow-up assessments. This population represents a group at risk of functional decline despite not requiring inpatient admission. By focusing on older adults discharged from the ED, the study aims to capture real-world outcomes in a population that is often underrepresented in research but commonly experiences falls and subsequent declines in independence.
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Presentation to the emergency department with a simple (non-injurious) fall
- Discharged from the ED without hospitalization
- Cognitively able to answer online or telephone follow-up interviews
Key exclusion criteria (4 listed)
- Falls due to traumatic events other than simple falls
- Hospital admission required after the fall
- Presence of acute confusion, dementia, or other severe cognitive impairment
- Inability to access online or telephone follow-up during the 30-day study period
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
Decline in Activities of Daily Living
Time frame: Baseline (ED discharge), 7 days, and 30 days after discharge
Change in Activities of Daily Living (ADL) score from baseline to follow-up. Decline is defined as an increase in dependency in at least one ADL item compared with baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Fall
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
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.
Şadiye Mıdık contact
Questions about this trial
What is this clinical trial studying?
An observational study of Fall and Daily Activities, run by Ege University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özge Can (+905054499887 ext. 5057521845, ozgece83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in Activities of Daily Living (time frame: Baseline (ED discharge), 7 days, and 30 days after discharge). 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 9 Sep 2025.