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

NCT ID: NCT03351413

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Fall Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

LIVE-LiFE to Prevent Falls Among Older Fallers

Intervention Type 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)

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type OTHER

Other Intervention Names

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LIVE-LiFE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah L Szanton, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32193981 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30606239 (View on PubMed)

Other Identifiers

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IRB00141297

Identifier Type: -

Identifier Source: org_study_id

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