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Preventing falls among older fallers : Study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program

Granbom, Marianne LU orcid ; Clemson, Lindy ; Roberts, Laken ; Hladek, Melissa D. ; Okoye, Safiyyah M. ; Liu, Minhui ; Felix, Cynthia ; Roth, David L. ; Gitlin, Laura N. and Szanton, Sarah (2019) In Trials 20(1).
Abstract

Background: Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program - the LIVE LiFE program - for community-living older adults. The program adapts and expands the successful Lifestyle Intervention Functional Exercise (LiFE) program by adding home safety, vision contrast screening, and medication review. The specific aims of the study are to (1) adapt the LiFE program to a US context and expand it into a multicomponent... (More)

Background: Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program - the LIVE LiFE program - for community-living older adults. The program adapts and expands the successful Lifestyle Intervention Functional Exercise (LiFE) program by adding home safety, vision contrast screening, and medication review. The specific aims of the study are to (1) adapt the LiFE program to a US context and expand it into a multicomponent program (LIVE LiFE) addressing intrinsic and extrinsic fall risks, (2) examine feasibility and acceptability, and (3) estimate program impact on multiple outcome measures to prepare for an efficacy trial. Methods: The study involves two phases: an open-label pilot, followed by a two-group, single-blinded randomized pilot trial. Eligible participants are community-living adults 70+ years reporting at least one injurious fall or two non-injurious falls in the previous year. Participants are randomized in a 2:1 ratio to the program group (LIVE LiFE, n = 25) or the control group (written fall risk assessment, n = 12). The open-label pilot participants (n = 3) receive the program without randomization and are assessed based on their experience, resulting in a stronger emphasis on the participant's personal goals being integrated into LIVE LiFE. Fall risk and balance outcomes are assessed by the Timed Up and Go and the 4-Stage Balance Test at 16 weeks. Additional outcomes are incidence of falls and near falls, falls efficacy, fear of falling, number of home hazards, and medications assessed at 16 weeks. Incidence of falls and near falls, program adherence, and satisfaction are assessed again at 32 weeks. Discussion: By expanding and adapting the evidence-based LiFE program, our study will help us understand the feasibility of conducting a multicomponent program and estimate its impact on multiple outcome measures. This will support moving forward with an efficacy trial of the LIVE LiFE program for older adults who are at risk of falling. Trial registration: ClinicalTrials.gov, NCT03351413. Registered on 22 November 2017.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Community-dwelling, Home hazards, Home visit, Lifestyle-integrated exercise, Medication review, Near falls, Occupational therapy, Older adults, Prevention, Vision screening
in
Trials
volume
20
issue
1
article number
2
publisher
BioMed Central (BMC)
external identifiers
  • pmid:30606239
  • scopus:85059497405
ISSN
1745-6215
DOI
10.1186/s13063-018-3114-5
project
Moving to age-in-place? Building evidence on community-based moves and home modification services as means to improve the home environment and decrease admission to skilled nursing facilities
language
English
LU publication?
yes
id
c47f7a59-4819-43de-9f7f-f97500f44bf7
date added to LUP
2019-01-18 13:16:28
date last changed
2024-06-11 02:52:35
@article{c47f7a59-4819-43de-9f7f-f97500f44bf7,
  abstract     = {{<p>Background: Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program - the LIVE LiFE program - for community-living older adults. The program adapts and expands the successful Lifestyle Intervention Functional Exercise (LiFE) program by adding home safety, vision contrast screening, and medication review. The specific aims of the study are to (1) adapt the LiFE program to a US context and expand it into a multicomponent program (LIVE LiFE) addressing intrinsic and extrinsic fall risks, (2) examine feasibility and acceptability, and (3) estimate program impact on multiple outcome measures to prepare for an efficacy trial. Methods: The study involves two phases: an open-label pilot, followed by a two-group, single-blinded randomized pilot trial. Eligible participants are community-living adults 70+ years reporting at least one injurious fall or two non-injurious falls in the previous year. Participants are randomized in a 2:1 ratio to the program group (LIVE LiFE, n = 25) or the control group (written fall risk assessment, n = 12). The open-label pilot participants (n = 3) receive the program without randomization and are assessed based on their experience, resulting in a stronger emphasis on the participant's personal goals being integrated into LIVE LiFE. Fall risk and balance outcomes are assessed by the Timed Up and Go and the 4-Stage Balance Test at 16 weeks. Additional outcomes are incidence of falls and near falls, falls efficacy, fear of falling, number of home hazards, and medications assessed at 16 weeks. Incidence of falls and near falls, program adherence, and satisfaction are assessed again at 32 weeks. Discussion: By expanding and adapting the evidence-based LiFE program, our study will help us understand the feasibility of conducting a multicomponent program and estimate its impact on multiple outcome measures. This will support moving forward with an efficacy trial of the LIVE LiFE program for older adults who are at risk of falling. Trial registration: ClinicalTrials.gov, NCT03351413. Registered on 22 November 2017.</p>}},
  author       = {{Granbom, Marianne and Clemson, Lindy and Roberts, Laken and Hladek, Melissa D. and Okoye, Safiyyah M. and Liu, Minhui and Felix, Cynthia and Roth, David L. and Gitlin, Laura N. and Szanton, Sarah}},
  issn         = {{1745-6215}},
  keywords     = {{Community-dwelling; Home hazards; Home visit; Lifestyle-integrated exercise; Medication review; Near falls; Occupational therapy; Older adults; Prevention; Vision screening}},
  language     = {{eng}},
  month        = {{01}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Preventing falls among older fallers : Study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program}},
  url          = {{http://dx.doi.org/10.1186/s13063-018-3114-5}},
  doi          = {{10.1186/s13063-018-3114-5}},
  volume       = {{20}},
  year         = {{2019}},
}