Fall AccidentNCT03294447
An Occupational Therapist Fall Prevention Intervention in a Geriatric Primary Care Setting
A study testing Fall Prevention by the Occupational Therapist in people with Fall Accident and Fall, Accidental, run by Rush University Medical Center at 1 site in United States.
Trial summary
Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Accident, Fall, Accidental
- What is being tested?
- Fall Prevention by the Occupational Therapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2017
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cognitively intact with a score of 29/30 or higher on the Orientation Log (standardized assessment tool)
- living in the community
- English speaking
- had a fall or near fall in the past year
Who cannot join
- received OT services within the past 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Geriatric Primary Care Clinic
Chicago, Illinois, 60612
About this study
Official title: The Association Between Fear of Falling and Fall Prevention Interventions Offered by an Occupational Therapist in a Geriatric Primary Care Setting
Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF.
The primary research question: Is there an association between fear of falling among geriatric populations and fall prevention interventions that are offered by occupational therapist in a geriatric primary care setting?
- Conditions
- Fall Accident, Fall, Accidental
- Being tested
- Fall Prevention by the Occupational Therapist
- Keywords
- Fear of falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall Prevention by the Occupational TherapistBehavioural
The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.
| Study group | Role | What they receive |
|---|---|---|
| Fall Prevention Intervention by OT | Experimental | Fall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office. Receives: Behavioral: Fall Prevention by the Occupational Therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling
The outcome measure is the change between the pre FES-I and post FES-I
Measured: One Time visit: 30-50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall AccidentStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Western Michigan University
- Responsible party
- Principal investigator, Lydia Royeen, Rush University Medical Center
- Investigators
- Lydia Royeen, Masters, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294447
- Sponsor's protocol ID
- 15082105-IRB01
- Status last verified
- Dec 2020
- First submitted
- 23 May 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Fear of Falling and Fall Prevention Interventions Offered by an Occupational Therapist in a Geriatric Primary Care Setting
- ClinicalTrials.gov ID
- NCT03294447
- Acronym / sponsor ID
- 15082105-IRB01
- Conditions
- Fall Accident, Fall, Accidental
- Keywords
- Fear of falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Western Michigan University
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Sep 2017 (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.
Purpose of the study: To identify if an intervention focused on decreasing fear of falling (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has the potential to decrease falls and improve physical, psychological and social factors related to FOF.
The primary research question: Is there an association between fear of falling among geriatric populations and fall prevention interventions that are offered by occupational therapist in a geriatric primary care setting?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fall Prevention Intervention by OT | Experimental | Behavioral: Fall Prevention by the Occupational TherapistFall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cognitively intact with a score of 29/30 or higher on the Orientation Log (standardized assessment tool)
- living in the community
- English speaking
- had a fall or near fall in the past year
Key exclusion criteria (1 listed)
- received OT services within the past 2 months
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 |
|---|---|---|
| Fall Prevention by the Occupational TherapistThe interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations. | Behavioural | Fall Prevention Intervention by OT |
Primary outcome
The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling
Time frame: One Time visit: 30-50 minutes
The outcome measure is the change between the pre FES-I and post FES-I
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Fall Accident
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Evaluation of the Relationship Between Fall Risk, Muscle Strength, and Anticholinergic Burden in Geriatric Patients Presenting to the Emergency Department
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Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk )
Aging, Fall
RecruitingObservational study
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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.
Lydia Royeen, Masters principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall Prevention by the Occupational Therapist in people with Fall Accident and Fall, Accidental, run by Rush University Medical Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 16 Dec 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling (time frame: One Time visit: 30-50 minutes). 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 Dec 2020; AzTrials last refreshed its copy on 2 Nov 2026.