Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program
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...
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doaj-545d32201a274ea2ac2709b76bcee9882020-11-25T02:37:12ZengBMCTrials1745-62152019-01-012011910.1186/s13063-018-3114-5Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE programMarianne Granbom0Lindy Clemson1Laken Roberts2Melissa D. Hladek3Safiyyah M. Okoye4Minhui Liu5Cynthia Felix6David L. Roth7Laura N. Gitlin8Sarah Szanton9Center for Innovative Care in Aging, Johns Hopkins School of NursingThe University of SydneyCenter for Innovative Care in Aging, Johns Hopkins School of NursingCenter for Innovative Care in Aging, Johns Hopkins School of NursingCenter for Innovative Care in Aging, Johns Hopkins School of NursingCenter for Innovative Care in Aging, Johns Hopkins School of NursingJohns Hopkins Bloomberg School of Public HealthCenter on Aging and Health, Johns Hopkins UniversityCollege of Nursing and Health Professions, Drexel UniversityCenter for Innovative Care in Aging, Johns Hopkins School of NursingAbstract 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.http://link.springer.com/article/10.1186/s13063-018-3114-5Older adultsPreventionLifestyle-integrated exerciseOccupational therapyCommunity-dwellingNear falls |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Marianne Granbom Lindy Clemson Laken Roberts Melissa D. Hladek Safiyyah M. Okoye Minhui Liu Cynthia Felix David L. Roth Laura N. Gitlin Sarah Szanton |
spellingShingle |
Marianne Granbom Lindy Clemson Laken Roberts Melissa D. Hladek Safiyyah M. Okoye Minhui Liu Cynthia Felix David L. Roth Laura N. Gitlin Sarah Szanton Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program Trials Older adults Prevention Lifestyle-integrated exercise Occupational therapy Community-dwelling Near falls |
author_facet |
Marianne Granbom Lindy Clemson Laken Roberts Melissa D. Hladek Safiyyah M. Okoye Minhui Liu Cynthia Felix David L. Roth Laura N. Gitlin Sarah Szanton |
author_sort |
Marianne Granbom |
title |
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program |
title_short |
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program |
title_full |
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program |
title_fullStr |
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program |
title_full_unstemmed |
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program |
title_sort |
preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent live life program |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-01-01 |
description |
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 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. |
topic |
Older adults Prevention Lifestyle-integrated exercise Occupational therapy Community-dwelling Near falls |
url |
http://link.springer.com/article/10.1186/s13063-018-3114-5 |
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