Accidental FallsNCT00590746
Bedside Assessment of Fall Risk in Emergency Department Elders
An observational study of Accidental Falls, run by Jeffrey Caterino at 1 site in United States.
Trial summary
The purpose of this study is to assess the risk for falls among elderly Emergency Department (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and the "Up and Go" test. These tests measure how steady a person is while standing, walking, and turning 180 degrees. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2009
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 and older who present to the Ohio State University Medical Center Emergency Department
Who may be able to join
- Age > 59 years
- Discharge from Emergency Department
- Self-reported weight < 300 pounds
- Patient resides in the community or a personal care home
- Patients must also confirm that they are able to walk 30 feet without help of another person.They may do this with use of an assistive device.
Who cannot join
- Age <60 years
- Subject is incarcerated
- Non-English speaking
- Lack of ability of patient to give consent or complete the study tasks
- Patient resides in a nursing home or rehabilitation facility
- Primary evaluation by the trauma team
- Inability to walk 30 feet without assistance from another person
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center Emergency Department
Columbus, Ohio, 43210
About this study
The purpose of this study is to assess the risk for falls among elderly Emergency Department (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and the "Up and Go" test. These tests measure how steady a person is while standing, walking, and turning 180 degrees. After patients have returned home, they will be contacted at 7 days, 30 days and 6 months to determine if they have sustained a fall during these intervals in order to find out how predictive the balance tests are in determining the risk of future falls.
Read the detailed description
Falls are one of the most significant health risks to older Americans. In the U.S., 30-60% of community dwelling elders will fall each year.Studies have found rates of serious injury among elders who fall to range from 5-24%. Five percent of those who fall are hospitalized. Among elders, falls cause 2/3 of the deaths due to unintentional injury, the 6th leading cause of death in this age group. Additional major morbidity due to falls includes loss of independence as well as anxiety due to fear of falling. This results in limitation of function and often in a requirement for long-term care. Up to 40% of nursing home admissions are due to falls or fear of falling. Expenditures for fall-related injuries account for 6% of all medical expenditures in geriatric patients. Several interventions have been proven effective to reduce rates of fall. Implementation of these interventions requires physician appreciation of the risk for falls in individual patients. The emergency department (ED) may provide a location to identify patients at increased risk of falling. Unfortunately, successful ED based studies to identify and intervene on at-risk elders have been rare and not widely reproducible. The results of these previous ED studies demonstrate that a rapid, efficient, measurable assessment of balance is required if emergency physicians are to regularly consider such factors in their care plans and disposition decisions. Development of a single, simple screening test to identify ED elders at who fall may improve falls screening in the ED and prevent unnecessary morbidity and mortality by facilitating early identification and intervention.
- Conditions
- Accidental Falls
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the accuracy of the timed Timed Up-and-go test in the ED
Measured: 1 year
To determine the accuracy of the Bertec BalanceCheck Screener system in the ED.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Caterino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Caterino, Ohio State University
- Investigators
- Jeffrey M Caterino, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590746
- Sponsor's protocol ID
- 2007H0239
- Status last verified
- Feb 2014
- First submitted
- 26 Dec 2007
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Assessment of Fall Risk in Emergency Department Elders
- ClinicalTrials.gov ID
- NCT00590746
- Acronym / sponsor ID
- 2007H0239
- Conditions
- Accidental Falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Jeffrey CaterinoUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- 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 purpose of this study is to assess the risk for falls among elderly Emergency Department (ED) patients.This study will use 2 tests of balance, the Bertec Balance Screening Test and the "Up and Go" test. These tests measure how steady a person is while standing, walking, and turning 180 degrees. After patients have returned home, they will be contacted at 7 days, 30 days and 6 months to determine if they have sustained a fall during these intervals in order to find out how predictive the balance tests are in determining the risk of future falls.
Detailed description
Falls are one of the most significant health risks to older Americans. In the U.S., 30-60% of community dwelling elders will fall each year.Studies have found rates of serious injury among elders who fall to range from 5-24%. Five percent of those who fall are hospitalized. Among elders, falls cause 2/3 of the deaths due to unintentional injury, the 6th leading cause of death in this age group. Additional major morbidity due to falls includes loss of independence as well as anxiety due to fear of falling. This results in limitation of function and often in a requirement for long-term care. Up to 40% of nursing home admissions are due to falls or fear of falling. Expenditures for fall-related injuries account for 6% of all medical expenditures in geriatric patients. Several interventions have been proven effective to reduce rates of fall. Implementation of these interventions requires physician appreciation of the risk for falls in individual patients. The emergency department (ED) may provide a location to identify patients at increased risk of falling. Unfortunately, successful ED based studies to identify and intervene on at-risk elders have been rare and not widely reproducible. The results of these previous ED studies demonstrate that a rapid, efficient, measurable assessment of balance is required if emergency physicians are to regularly consider such factors in their care plans and disposition decisions. Development of a single, simple screening test to identify ED elders at who fall may improve falls screening in the ED and prevent unnecessary morbidity and mortality by facilitating early identification and intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 and older who present to the Ohio State University Medical Center Emergency Department
Key inclusion criteria (5 listed)
- Age > 59 years
- Discharge from Emergency Department
- Self-reported weight < 300 pounds
- Patient resides in the community or a personal care home
- Patients must also confirm that they are able to walk 30 feet without help of another person.They may do this with use of an assistive device.
Key exclusion criteria (7 listed)
- Age <60 years
- Subject is incarcerated
- Non-English speaking
- Lack of ability of patient to give consent or complete the study tasks
- Patient resides in a nursing home or rehabilitation facility
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
To determine the accuracy of the timed Timed Up-and-go test in the ED
Time frame: 1 year
To determine the accuracy of the Bertec BalanceCheck Screener system in the ED.
Time frame: 1 year
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 13 Feb 2014.
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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.
Jeffrey M Caterino, MD principal investigator
Ohio State University
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 Accidental Falls, run by Jeffrey Caterino 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 5 inclusion and 7 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 13 Feb 2014. 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?
To determine the accuracy of the timed Timed Up-and-go test in the ED (time frame: 1 year). The study lists 2 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 13 Feb 2014.