Clinical trial NCT03351413: Preventing Falls Among Older Fallers to Test the Effect of LIVE-LiFE, a Home-Based, Tailored Fall Prevention Program
Official title: SAFE-LiFE to Prevent Falls Among Older Fallers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention
Keywords: Fall Prevention
Older Adults
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Times Up and Go Test
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Falls Self-Efficacy
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sarah L Szanton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.