- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554437
Kenosha County Falls Prevention Study
July 12, 2023 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
349
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Intermediate-intensity, community-based, multifactorial falls intervention
|
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.
|
|
Active Comparator: 2
Occupational therapist home safety evaluation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of falls
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
all-cause hospitalizations
Time Frame: one year
|
one year
|
|
nursing home utilizations: number of days and number of admissions
Time Frame: one year
|
one year
|
|
change in ADL function from baseline to one year
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jane E Mahoney, MD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
November 2, 2007
First Submitted That Met QC Criteria
November 2, 2007
First Posted (Estimated)
November 6, 2007
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
November 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 2002-Prevention Funding
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.