Accidental FallsNCT00554437
Kenosha County Falls Prevention Study
A study testing UW Falls Prevention Program in people with Accidental Falls, run by University of Wisconsin, Madison.
Trial summary
Intensive falls prevention programs have been shown to be effective in reducing falls; however, a number of practical programs, based in community setting have not been successful at reducing rate of falls. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- UW Falls Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jun 2004
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 and older
- a history of two falls in the previous year or one fall in the previous two years with injury or gait and balance problems
- independently living in Kenosha County
Who cannot join
- unable to give informed consent with no related caregiver in the home
- enrolled in hospice
- living in an assisted-living facility
- expecting to move away permanently from the area
About this study
Official title: Kenosha County Falls Prevention Study: An Intermediate-intensity, Community-based, Multifactorial Intervention
Intensive falls prevention programs have been shown to be effective in reducing falls; however, a number of practical programs, based in community setting have not been successful at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled trial, the efficacy of this intermediate-intensity, individual, multifactorial model to reduce falls. It was hypothesized that more contacts would lead to greater adherence and efficacy in reducing falls.
- Conditions
- Accidental Falls
- Being tested
- UW Falls Prevention Program
- Keywords
- Accidental Falls, RCT, Age 65 and older, noninstitualized populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UW Falls Prevention ProgramBehavioural
The intervention model is of a community-based multifactorial intervention that links participants to existing medical care and service networks. The intervention used an algorithm based on the University of Wisconsin Falls Prevention Clinic, designed to identify predisposing factors for falls; induce risk reduction changes in medical conditions, medications, behavior, physical status, and home environment through recommendations to participants and their physicians; and make sure these changes are long-lasting through follow-up and linkages to other care networks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intermediate-intensity, community-based, multifactorial falls intervention Receives: Behavioral: UW Falls Prevention Program |
| 2 | Active comparator | Occupational therapist home safety evaluation Receives: Behavioral: UW Falls Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of falls
Measured: one year
Secondary outcomes (3)
all-cause hospitalizations
Measured: one year
nursing home utilizations: number of days and number of admissions
Measured: one year
change in ADL function from baseline to one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startMay 2002
- Study completionJun 2004
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Kenosha County Aging and Disability Resource Center, Wisconsin Department of Health and Family Services
- Responsible party
- Sponsor
- Investigators
- Jane E Mahoney, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554437
- Sponsor's protocol ID
- 2002-Prevention Funding
- Status last verified
- Nov 2008
- First submitted
- 2 Nov 2007
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahoney JE, Shea TA, Przybelski R, Jaros L, Gangnon R, Cech S, Schwalbe A. Kenosha County falls prevention study: a randomized, controlled trial of an intermediate-intensity, community-based multifactorial falls intervention. J Am Geriatr Soc. 2007 Apr;55(4):489-98. doi: 10.1111/j.1532-5415.2007.01144.x.
PubMed 17397425
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kenosha County Falls Prevention Study: An Intermediate-intensity, Community-based, Multifactorial Intervention
- ClinicalTrials.gov ID
- NCT00554437
- Acronym / sponsor ID
- 2002-Prevention Funding
- Conditions
- Accidental Falls
- Keywords
- Accidental Falls, RCT, Age 65 and older, noninstitualized populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Kenosha County Aging and Disability Resource Center, Wisconsin Department of Health and Family Services
- Study start
- May 2002
- Study completion
- Jun 2004 (actual)
- First posted
- 6 Nov 2007 (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.
Intensive falls prevention programs have been shown to be effective in reducing falls; however, a number of practical programs, based in community setting have not been successful at reducing rate of falls. The purpose of this study was to test, in a randomized, controlled trial, the efficacy of this intermediate-intensity, individual, multifactorial model to reduce falls. It was hypothesized that more contacts would lead to greater adherence and efficacy in reducing falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: UW Falls Prevention ProgramIntermediate-intensity, community-based, multifactorial falls intervention |
| 2 | Active comparator | Behavioral: UW Falls Prevention ProgramOccupational therapist home safety evaluation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged 65 and older
- a history of two falls in the previous year or one fall in the previous two years with injury or gait and balance problems
- independently living in Kenosha County
Key exclusion criteria (4 listed)
- unable to give informed consent with no related caregiver in the home
- enrolled in hospice
- living in an assisted-living facility
- expecting to move away permanently from the area
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 |
|---|---|---|
| UW Falls Prevention ProgramThe intervention model is of a community-based multifactorial intervention that links participants to existing medical care and service networks. The intervention used an algorithm based on the University of Wisconsin Falls Prevention Clinic, designed to identify predisposing factors for falls; induce risk reduction changes in medical conditions, medications, behavior, physical status, and home environment through recommendations to participants and their physicians; and make sure these changes are long-lasting through follow-up and linkages to other care networks. | Behavioural | 1, 2 |
Primary outcome
rate of falls
Time frame: one year
3 secondary outcomes
all-cause hospitalizations
Time frame: one year
nursing home utilizations: number of days and number of admissions
Time frame: one year
change in ADL function from baseline to one year
Time frame: one 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 14 Jul 2023.
- Results publication: PubMed 17397425Mahoney JE, Shea TA, Przybelski R, Jaros L, Gangnon R, Cech S, Schwalbe A. Kenosha County falls prevention study: a randomized, controlled trial of an intermediate-intensity, community-based multifactorial falls intervention. J Am Geriatr Soc. 2007 Apr;55(4):489-98. doi: 10.1111/j.1532-5415.2007.01144.x.
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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.
Jane E Mahoney, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing UW Falls Prevention Program in people with Accidental Falls, run by University of Wisconsin, Madison.
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 3 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: finished, as of the sponsor's last update on 14 Jul 2023. 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?
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?
rate of falls (time frame: one year). 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 NCT00554437, 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 14 Jul 2023.