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

Marianne Granbom, Lindy Clemson, Laken Roberts, Melissa D Hladek, Safiyyah M Okoye, Minhui Liu, Cynthia Felix, David L Roth, Laura N Gitlin, Sarah Szanton, Marianne Granbom, Lindy Clemson, Laken Roberts, Melissa D Hladek, Safiyyah M Okoye, Minhui Liu, Cynthia Felix, David L Roth, Laura N Gitlin, Sarah Szanton

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.

Keywords: Community-dwelling; Home hazards; Home visit; Lifestyle-integrated exercise; Medication review; Near falls; Occupational therapy; Older adults; Prevention; Vision screening.

Conflict of interest statement

Ethics approval and consent to participate

The participants provide written informed consent before baseline data collection. The Johns Hopkins University Institutional Review Board in Baltimore, MD (IRB00141297) approved the study. Study sponsor is Johns Hopkins Center for Injury Research at Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205. The sponsor 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.

Consent for publication

Not applicable.

Competing interests

Dr. Clemson is a co-developer of the LiFE program and led the original randomized trial, proving its effectiveness. All other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of LIVE LiFE enrollment, interventions, and assessments adapted from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

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