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OpenTrials
Completed

NCT Number: NCT03351413

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

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

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Key information

Conditions

Fall Prevention

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIVE-LiFE to Prevent Falls Among Older Fallers

Other

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)

Other names: LIVE-LiFE

Primary outcomes

  1. Times Up and Go Test

    Time frame: Baseline to 16 weeks

    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.

Secondary outcomes

  1. Falls Self-Efficacy

    Time frame: Baseline to 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

SAFE-LiFE to Prevent Falls Among Older Fallers

Acronym: LIVE-LiFE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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