TY - JOUR
T1 - Preventing falls among older fallers
T2 - Study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program
AU - Granbom, Marianne
AU - Clemson, Lindy
AU - Roberts, Laken
AU - Hladek, Melissa D.
AU - Okoye, Safiyyah M.
AU - Liu, Minhui
AU - Felix, Cynthia
AU - Roth, David L.
AU - Gitlin, Laura N.
AU - Szanton, Sarah
N1 - Funding Information:
The study is funded by the Centers for Disease Control and Prevention (RF: R49CE002466) and conducted at the Center for Innovative Care in Aging at Johns Hopkins University School of Nursing. MG is supported by the Swedish Research Council FORMAS (RF: 942-2015-403), The Crafoord Foundation, Sweden (RF: 20160604), and The Helge Ax:son Johnsons Foundation, Sweden. The funding sources had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/1/3
Y1 - 2019/1/3
N2 - 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.
AB - 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.
KW - Community-dwelling
KW - Home hazards
KW - Home visit
KW - Lifestyle-integrated exercise
KW - Medication review
KW - Near falls
KW - Occupational therapy
KW - Older adults
KW - Prevention
KW - Vision screening
UR - http://www.scopus.com/inward/record.url?scp=85059497405&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85059497405&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-3114-5
DO - 10.1186/s13063-018-3114-5
M3 - Article
C2 - 30606239
AN - SCOPUS:85059497405
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 2
ER -