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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. 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.

SUBMITTER: Granbom M

PROVIDER: S-EPMC6318957 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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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 M Clemson Lindy L Roberts Laken L Hladek Melissa D MD Okoye Safiyyah M SM Liu Minhui M Felix Cynthia C Roth David L DL Gitlin Laura N LN Szanton Sarah S

Trials 20190103 1

<h4>Background</h4>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 Lifes ...[more]

PMID: 30606239

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Project description:BackgroundFalls represent important drivers of intrinsic capacity losses, functional limitations and reduced quality of life in the growing older adult's population, especially among those presenting with frailty. Despite exercise- and cognitive training-based interventions have shown effectiveness for reducing fall rates, evidence around their putative cumulative effects on falls and fall-related complications (such as fractures, reduced quality of life and functional limitations) in frail individuals remains scarce. The main aim of this study is to explore the effectiveness program combining an individualized exercise program and an executive function-based cognitive training (VIVIFRAIL-COGN) compared to usual care in the prevention of falls and fall-related outcomes over a 1-year follow-up.MethodsThis study is designed as a four-center randomized clinical trial with a 12-week intervention period and an additional 1-year follow-up. Three hundred twenty frail or pre-frail (≥ 1 criteria of the Frailty Phenotype) older adults (≥ 75 years) with high risk of falling (defined by fall history and gait performance) will be recruited in the Falls Units of the participating centers. They will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will participate in a home-based intervention combining the individualized Vivifrail multicomponent (aerobic, resistance, gait and balance and flexibility) exercise program and a personalized executive function-based cognitive training (VIVIFRAIL-COGN). The CG group will receive usual care delivered in the Falls Units, including the Otago Exercise Program. Primary outcome will be the incidence of falls (event rate/year) and will be ascertained by self-report during three visits (at baseline, and 6 and 12 weeks) and telephone-based contacts at 6, 9 and 12 months after randomization. Secondarily, effects on measures of physical and cognitive function, quality of life, nutritional, muscle quality and psychological status will be evaluated.DiscussionThis trial will provide new evidence about the effectiveness of an individualized multidomain intervention by studying the effect of additive effects of cognitive training and physical exercise to prevent falls in older frail persons with high risk of falling. Compared to usual care, the combined intervention is expected to show additive effects in the reduction of the incidence of falls and associated adverse outcomes.Trial registrationNCT04911179 02/06/2021.

Project description:BackgroundFalls are the leading cause of injury-related mortality and hospitalization among adults aged ≥ 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs.MethodsA multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged ≥ 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patient's consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression.DiscussionThe findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries.Trial registrationClinicalTrials.gov NCT05449470 (7-7-2022).

Dataset Information

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

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

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