Accidental FallsNCT00363246
Characterizing Wheelchair-Related Falls in Elderly Veterans
An observational study of Accidental Falls, run by US Department of Veterans Affairs at 2 sites in 2 countries.
Trial summary
The purpose of this study is to find out about the risk factors for wheelchair-related falls among elderly veterans, and to find out about the costs and consequences of those falls. Read more about this study
- Who is it for?
- Ages 62 years and older
- Conditions the study is for
- Accidental Falls
- How many people
- 766 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2007to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 62 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly wheelchair users
Who may be able to join
- veteran
- aged 62 and older
- use a wheelchair for their primary means of mobility
- have used a wheelchair for at least 12 months previous to enrollment
- will be using a wheelchair for at least the next 12 months
Who cannot join
- not living in a community-based setting
- no access to a telephone
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
James A. Haley Veterans Hospital
Tampa, Florida, 33637-1022
About this study
The purpose of this study is to find out about the risk factors for wheelchair-related falls among elderly veterans, and to find out about the costs and consequences of those falls.
Read the detailed description
Rationale and Objectives. A multitude of risk factors for falls has been reported, however many of these risk factors are not applicable to persons who use a wheelchair for mobility. Specific objectives include: (1) Describe the incidence and prevalence of wheelchair tips (near falls), falls, and fall-related injuries, (2) Describe the epidemiology of the wheelchair tip or fall event. (3) Create models for predicting wheelchair tips, falls, and fall-related injuries for elderly persons who use a wheelchair for mobility. (4) Determine healthcare utilization and direct costs associated with wheelchair-related fall injuries. (5) Describe patient perceived short- and long-term consequences of wheelchair-related falls.
Research Design. This 3-year prospective cohort study includes qualitative and quantitative data collected at baseline data and through monthly follow-up phone interviews over a 12-month period. Data Source. Baseline data on demographics, intrinsic risk factors, and extrinsic risk factors will be collected through interviews. We will assess functional status, cognition, and home management skills through standardized tools. Administrative databases will be used to gather data regarding comorbidities, Veterans Health Administration (VHA) health care utilization and direct costs. A physical therapy assistant will also conduct a wheelchair inventory and wheelchair skills test. Monthly follow-up phone interviews will include number of falls, description of the fall event/mechanism and nature of the injury, changes in modifiable risk factors, and description of injury and treatment. A separate phone interview will be conducted with a subset of subjects at 6 months post fall, using open-ended questions to gather data about patient-perceived long-term consequences of falls. At the end of the 12-month data collection, we will reassess patient's functional status and cognition. Sample. Inclusion criterion includes all veterans who (1) are aged 62 and older, (2) use a wheelchair for their primary means of mobility, (3) have used a wheelchair for at least 12 months previous to enrollment, and (4) will be using a wheelchair for at least the next 12 months. Exclusion criteria (1) no longer living in a community-based setting (e.g., admitted to nursing home), (2) do not have a telephone. We will over sample women and minorities. A total of 882 subjects are needed for a power of 0.8 and an alpha of 0.05 with an anticipated drop out rate of 30%. Analysis. Bivariate analysis will be performed to determine relationships between outcomes and risk factors. Logistic regression models for predicting wheelchair-related tips, falls and fall-related injuries will be developed based on the most important intrinsic and extrinsic risk factors, controlling for possible confounders. Falls will also be analyzed according to a survival-analysis technique. Univariate and multiple Cox regression will be used to assess the associations of different independent variables with the injurious fall. The cost analysis estimates the net or marginal costs of wheelchair users who experience a wheelchair fall accident and seek medical advice or treatment. We use a dichotomous fall (generating medical expense) variable for a "with" or "without" analysis to compare the average cost of medical care for wheelchair users without a fall involving medical observation or care to the average cost of those that did have a serious fall (including death). The difference between these two groups is a proxy of the cost of utilization due to the fall. Multivariate regression analysis will be used to gauge the net effects of a fall on costs, controlling for the wider array of factors that drive cost of treatment and thereby potentially confound univariate analysis. The control variables are demographic including co-morbid conditions and healthcare related.
Anticipated Impact. Our project is expected to identify previously unaccounted for factors that predispose persons who use a wheelchair to falls and fall-related injuries. We will create models for predicting wheelchair tips, falls, and fall-related injuries. These models will be used to develop an evidence-based, patient centered wheelchair falls prevention program targeting modifiable risk factors. Findings from this study will be so used to develop an instrument to identify fall risk in elderly wheelchair users as well as an evidenced-based prevention program. We will partner with the VA National Center for Patient Safety to disseminate these products nationally in the VHA.
- Conditions
- Accidental Falls
- Keywords
- Elderly, Fall risk, Veterans, WheelChairs, Injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Older veterans who use a wheelchair for their primary means of mobility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair-related Falls
Wheelchair-related falls in 1 year follow-up period.
Measured: one year follow-up period
Secondary outcomes (1)
Injuries From Wheelchair-related Falls
Wheelchair-related falls that resulted in an injury in the one year follow up period
Measured: one year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJun 2007
- Primary completionNov 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 766 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrea M Spehar, DVM MPH JD, Principal investigator, VA Central Office - HSR&D, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363246
- Sponsor's protocol ID
- E4460-R
- Status last verified
- Jul 2015
- First submitted
- 10 Aug 2006
- Last updated
- 29 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Wheelchair-Related Falls in Elderly Veterans
- ClinicalTrials.gov ID
- NCT00363246
- Acronym / sponsor ID
- E4460-R
- Conditions
- Accidental Falls
- Keywords
- Elderly, Fall risk, Veterans, WheelChairs, Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 766 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 29 Jul 2015
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 find out about the risk factors for wheelchair-related falls among elderly veterans, and to find out about the costs and consequences of those falls.
Detailed description
Rationale and Objectives. A multitude of risk factors for falls has been reported, however many of these risk factors are not applicable to persons who use a wheelchair for mobility. Specific objectives include: (1) Describe the incidence and prevalence of wheelchair tips (near falls), falls, and fall-related injuries, (2) Describe the epidemiology of the wheelchair tip or fall event. (3) Create models for predicting wheelchair tips, falls, and fall-related injuries for elderly persons who use a wheelchair for mobility. (4) Determine healthcare utilization and direct costs associated with wheelchair-related fall injuries. (5) Describe patient perceived short- and long-term consequences of wheelchair-related falls.
Research Design. This 3-year prospective cohort study includes qualitative and quantitative data collected at baseline data and through monthly follow-up phone interviews over a 12-month period. Data Source. Baseline data on demographics, intrinsic risk factors, and extrinsic risk factors will be collected through interviews. We will assess functional status, cognition, and home management skills through standardized tools. Administrative databases will be used to gather data regarding comorbidities, Veterans Health Administration (VHA) health care utilization and direct costs. A physical therapy assistant will also conduct a wheelchair inventory and wheelchair skills test. Monthly follow-up phone interviews will include number of falls, description of the fall event/mechanism and nature of the injury, changes in modifiable risk factors, and description of injury and treatment. A separate phone interview will be conducted with a subset of subjects at 6 months post fall, using open-ended questions to gather data about patient-perceived long-term consequences of falls. At the end of the 12-month data collection, we will reassess patient's functional status and cognition. Sample. Inclusion criterion includes all veterans who (1) are aged 62 and older, (2) use a wheelchair for their primary means of mobility, (3) have used a wheelchair for at least 12 months previous to enrollment, and (4) will be using a wheelchair for at least the next 12 months. Exclusion criteria (1) no longer living in a community-based setting (e.g., admitted to nursing home), (2) do not have a telephone. We will over sample women and minorities. A total of 882 subjects are needed for a power of 0.8 and an alpha of 0.05 with an anticipated drop out rate of 30%. Analysis. Bivariate analysis will be performed to determine relationships between outcomes and risk factors. Logistic regression models for predicting wheelchair-related tips, falls and fall-related injuries will be developed based on the most important intrinsic and extrinsic risk factors, controlling for possible confounders. Falls will also be analyzed according to a survival-analysis technique. Univariate and multiple Cox regression will be used to assess the associations of different independent variables with the injurious fall. The cost analysis estimates the net or marginal costs of wheelchair users who experience a wheelchair fall accident and seek medical advice or treatment. We use a dichotomous fall (generating medical expense) variable for a "with" or "without" analysis to compare the average cost of medical care for wheelchair users without a fall involving medical observation or care to the average cost of those that did have a serious fall (including death). The difference between these two groups is a proxy of the cost of utilization due to the fall. Multivariate regression analysis will be used to gauge the net effects of a fall on costs, controlling for the wider array of factors that drive cost of treatment and thereby potentially confound univariate analysis. The control variables are demographic including co-morbid conditions and healthcare related.
Anticipated Impact. Our project is expected to identify previously unaccounted for factors that predispose persons who use a wheelchair to falls and fall-related injuries. We will create models for predicting wheelchair tips, falls, and fall-related injuries. These models will be used to develop an evidence-based, patient centered wheelchair falls prevention program targeting modifiable risk factors. Findings from this study will be so used to develop an instrument to identify fall risk in elderly wheelchair users as well as an evidenced-based prevention program. We will partner with the VA National Center for Patient Safety to disseminate these products nationally in the VHA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Older veterans who use a wheelchair for their primary means of mobility. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly wheelchair users
Key inclusion criteria (5 listed)
- veteran
- aged 62 and older
- use a wheelchair for their primary means of mobility
- have used a wheelchair for at least 12 months previous to enrollment
- will be using a wheelchair for at least the next 12 months
Key exclusion criteria (2 listed)
- not living in a community-based setting
- no access to a telephone
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
Wheelchair-related Falls
Time frame: one year follow-up period
Wheelchair-related falls in 1 year follow-up period.
1 secondary outcome
Injuries From Wheelchair-related Falls
Time frame: one year follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrea M Spehar, DVM MPH JD principal investigator
VA Central Office - HSR&D, Washington, DC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls, run by US Department of Veterans Affairs at 2 sites in 2 countries.
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 2 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wheelchair-related Falls (time frame: one year follow-up period). 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 29 Jul 2015.