Dataset Information

Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial.

ABSTRACT:

Background

The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness.

Methods

In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well.

Discussion

Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls.

Trial registration

ClinicalTrials.gov NCT03462654 . Registered on March 12, 2018.

SUBMITTER: Jansen CP

PROVIDER: S-EPMC6219201 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Perceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs. WTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75). The mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (-€32, 95% CI [- 65, - 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to <€2000). The net benefit for gLiFE was positive in most cases. Due to higher intervention costs of LiFE compared to gLiFE (€298 vs. €113), the net benefit for LiFE was negative for the majority of the sample, even at a subsidy of €75. The results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.

Project description:BACKGROUND:Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. OBJECTIVE:This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. METHODS:Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. RESULTS:The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. CONCLUSIONS:Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. TRIAL REGISTRATION:ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW).

Project description:BackgroundFall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany.MethodsA Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses.ResultsThe budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling.ConclusionsThe results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants).Trial registrationThe study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

Project description:IntroductionLifestyle-integrated Functional Exercise (LiFE) is an effective, individually delivered fall prevention program but comes with substantial resource requirements; hence, a group-format was developed (gLiFE). This study 1) evaluates the program content of two different LiFE formats (group vs individual) and 2) examines the relationship between predictors of training response (dose) and improvements in balance, strength, and physical activity (PA) (response).Material and methodsThe analysis included n = 252 (gLiFE = 126, LiFE = 126) community-dwelling older adults (78.6±5.2 years). LiFE was administered in seven sessions either in a group (gLiFE: 8-12 participants) or individually at home (LiFE). Questionnaire-based, descriptive content evaluation (frequency distributions) included reported frequency of practice (days/week, number of activities), activity preferences, safety, intensity, integrability of activities, and acceptance after 6 months of LiFE practice. Predictors (ie, dose [reported frequency and intensity], safety, and integrability of activities) for improvements in balance, strength, and PA were analyzed using radar charts.ResultsIn both formats, 11.2 activities were practiced on average. Strength activities were more frequently selected than balance. Content evaluation showed some marginal advantages for the LiFE participants for selected aspects. The effects on balance, strength, and PA were nearly similar in both groups. Participants who performed balance activities more frequently (≥4 days/week) scored better in the balance and PA domain. Those who performed strength activities more frequently (≥4 days/week) performed better in all three outcomes. Higher perceived safety was associated with better performance. Those who reported activities as "not physically exhausting" performed better in all three outcomes. Those who found activities easily integrable into daily routines scored higher in the balance and strength domain.Discussion and conclusionOverall, both program formats are comparable with respect to content evaluation and effects. Participants need to perceive the activities as safe, not exhausting, and should practice ≥4 days/week to generate a high benefit from the intervention.Trial registrationClinicalTrials.gov, NCT03462654. Registered on 12 March 2018.