Preventing Falls Among Older Fallers to Test the Effect of LIVE-LiFE, a Home-Based, Tailored Fall Prevention Program

Fall Prevention Clinical Trial

— LIVE-LiFE  

Official title:

SAFE-LiFE to Prevent Falls Among Older Fallers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351413
• Other study ID #: IRB00141297
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: To test the effect of LIVE-LiFE, a home-based, tailored fall prevention program for older adults with a high risk for falling.

Study Type: Single-blind, two group randomized pilot trial. Randomization is 2:1 (27 intervention, 13 control). Participants have a chance of being in the LIVE-LiFE group or the control group.

Safe-LiFE Group: Individually tailored intervention at the participant's home spaced across 12 weeks including:

• Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls

• Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk

• Medication review and feedback concerning medications with increased fall risk

Control Group:

• An individualized fall risk assessment provided to participant and their primary care provider

Sample: 40 community-dwelling older adults in Baltimore City or County

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Adults = 70 or older

• Self-report of 2 or more falls in the past 12 months OR 1 fall causing injury in the past 12 months

Exclusion Criteria:

• Moderate-severe memory problems

• No conversational English

• Not able to stand

• Resident in a nursing home or assisted living facility

• Hospitalized > 3 times in the last year

• Terminally ill (<1 year expected survival)

• Receiving active cancer treatment

Related Conditions & MeSH terms

• Fall Prevention

Intervention

Other:
• LIVE-LiFE to Prevent Falls Among Older Fallers
LIVE-LiFE Intervention: Individually tailored program at the participant's home spaced across 12 weeks including: Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk Medication review and feedback concerning medications with increased fall risk Measurement intervals: Baseline, 4 months, 8 months (with $25 gift card given at each visit for your time)

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Times Up and Go Test	A test used to assess the length of time it takes a person to get out of a chair, walk 10 feet, turn around and sit back down in the same chair.	Baseline to 16 weeks
Secondary	Falls Self-Efficacy	The confidence a person has in their ability to walk without falling measured via a 10-item Likert -type 10-point scale with score ranges from 10-100, where 10 is low confidence and 100 is high confidence in their ability to perform various activities without falling.	Baseline to 16 weeks