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

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ClinicalTrials.gov Identifier: NCT03351413
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Johns Hopkins University

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


Condition or disease Intervention/treatment Phase
Fall Prevention Other: LIVE-LiFE to Prevent Falls Among Older Fallers Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: SAFE-LiFE to Prevent Falls Among Older Fallers
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: 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
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)

Other Name: LIVE-LiFE

No Intervention: Control
- An individualized fall risk assessment provided to participant and their primary care provider



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351413


Contacts
Contact: Melissa D Hladek, PhD(c) 410-955-2219 mhladek1@jhu.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Hladek         
Sponsors and Collaborators
Johns Hopkins University
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Sarah L Szanton, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03351413     History of Changes
Other Study ID Numbers: IRB00141297
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Fall Prevention
Older Adults