Dane County Safety Assessment (SAFE) Research Study
| Tracking Information | |||||
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| First Received Date ICMJE | August 30, 2005 | ||||
| Last Updated Date | August 30, 2005 | ||||
| Start Date ICMJE | October 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Decreased fall rates | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dane County Safety Assessment (SAFE) Research Study | ||||
| Official Title ICMJE | Dane County Safety Assessment for Elders (SAFE) Research Study | ||||
| Brief Summary | A randomized controlled trial to assess the effectiveness of an at-home comprehensive approach to preventing falls among adults 65 years and older at high risk for falls. |
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| Detailed Description | A randomized controlled trial to assess the effectiveness of a comprehensive approach to preventing falls among adults 65 years and older at high risk for falls. This intervention includes a comprehensive health assessment in each participant's home combined with tailored risk reduction strategies such as individualized strength and balance exercises. The study is also conducting a community-based program to engage and educate physicians about fall prevention. The goal of the study is to demonstrate a 40% decrease in fall rates. Other expected outcomes include decreased hospital and nursing home stays, improved physical function, and a decreased fear of falling. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Falls | ||||
| Intervention ICMJE | Behavioral: Exercise, fall risk reduction | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 455 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Adults age 65+, at high risk for falls, - Exclusion Criteria: Adults <65 years - |
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00140322 | ||||
| Other Study ID Numbers ICMJE | CDC-NCIPC-3954, U17/CCU522465 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | August 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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