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

NCT03351413 | Completed

• 1 other identifier: IRB00141297
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fall Prevention

Keywords

Fall Prevention; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Falls Self-Efficacy

  Baseline to 16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

LIVE-LiFE to Prevent Falls Among Older Fallers Intervention, which is an 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

Other: LIVE-LiFE to Prevent Falls Among Older Fallers

Control

NO INTERVENTION

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

Interventions

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)

Also known as: LIVE-LiFE

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Szanton SL, Clemson L, Liu M, Gitlin LN, Hladek MD, LaFave SE, Roth DL, Marx KA, Felix C, Okoye SM, Zhang X, Bautista S, Granbom M. Pilot Outcomes of a Multicomponent Fall Risk Program Integrated Into Daily Lives of Community-Dwelling Older Adults. J Appl Gerontol. 2021 Mar;40(3):320-327. doi: 10.1177/0733464820912664. Epub 2020 Mar 20.

  PMID: 32193981 DERIVED

• Granbom M, Clemson L, Roberts L, Hladek MD, Okoye SM, Liu M, Felix C, Roth DL, Gitlin LN, Szanton S. Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program. Trials. 2019 Jan 3;20(1):2. doi: 10.1186/s13063-018-3114-5.

  PMID: 30606239 DERIVED

Study Officials

• Sarah L Szanton, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: July 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: August 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)