Dane County Safety Assessment (SAFE) Research Study | NCT00140322

Studies
Dane County Safety Assessment (SAFE) Research Study

NCT00140322

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 19, 2025Actual

Enrollment

455

Phase

Not Applicable

Conditions

Falls

Interventions

Exercise, fall risk reduction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U17/CCU522465

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2025

Last Update Posted Date

Mar 19, 2025Actual

Name	Class
Wisconsin Department of Health and Family Services	OTHER_GOV
University of Wisconsin, Madison	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

455

Name	Type	Description	Arm Group Labels	Other Names
Exercise, fall risk reduction	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decreased fall rates

Secondary Outcomes

Measure	Description	Time Frame
decreased hospital and nursing home stays
improved physical function
decreased fear of falling

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Adults age 65+, at high risk for falls, -

Exclusion Criteria: Adults <65 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jane Mahoney, MD	University of Wisconsin Medical School	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33560097	Derived	Garbez N, Mbatchi LC, Maseda E, Luque S, Grau S, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. A Loading Micafungin Dose in Critically Ill Patients Undergoing Continuous Venovenous Hemofiltration or Continuous Venovenous Hemodiafiltration: A Population Pharmacokinetic Analysis. Ther Drug Monit. 2021 Dec 1;43(6):747-755. doi: 10.1097/FTD.0000000000000874.

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena