Dataset Information

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

ABSTRACT: OBJECTIVES:While the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention. DESIGN:A single-centre wait-list randomised controlled study. SETTING:MS service in secondary care. PARTICIPANTS:Ambulatory, relatively inactive people with clinically confirmed MS. INTERVENTION:Thirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources. OUTCOMES:Included self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants' experiences and, at study end, the two Mii-vitaliSe facilitators' experiences of intervention delivery (main qualitative findings reported separately). RESULTS:Mean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27?min/day. Mean cost of delivering Mii-vitaliSe was £684 per person. DISCUSSION:Mii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design. TRIAL REGISTRATION:ISRCTN49286846.

SUBMITTER: Thomas S

PROVIDER: S-EPMC5623500 | biostudies-other | 2017 Sep

REPOSITORIES: biostudies-other

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Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

Thomas Sarah S Fazakarley Louise L Thomas Peter W PW Collyer Sarah S Brenton Sarah S Perring Steve S Scott Rebecca R Thomas Fern F Thomas Charlotte C Jones Kelly K Hickson Jo J Hillier Charles C

BMJ open 20170927 9

<h4>Objectives</h4>While the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.<h4>Design</h4>A single-cen ...[more]

PMID: 28954791

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Project description:IntroductionThe singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases.Trial registration numberNCT03076736.

Project description:BackgroundWell-being apps represent a promising and scalable approach for improving mental health outcomes in youth, especially during a global pandemic when access to face-to-face interventions may be limited. Whitu (meaning 7 in the New Zealand Māori language Te Reo) is a newly developed well-being app with 7 modules that support young people to learn and practice evidence-based coping skills, including relaxation, mindfulness, self-compassion, and goal-setting.ObjectiveDuring this pilot, we explored the acceptability, usability, and preliminary efficacy of Whitu before refining the app for a randomized controlled trial (RCT).MethodsWe recruited 20 New Zealand young people aged 16-25 years via social media to trial the first prototype of the Whitu app over 6 weeks. Within-group differences from baseline to 2- and 6-weeks post intervention in self-reported well-being, depression, anxiety, stress, self-compassion, optimism and sleep quality were evaluated using repeated-measures ANOVA. A further 21 participants aged 16-30 years were recruited to participate in 4 focus groups to give feedback on the app's usability and cultural acceptability. Feedback was analysed using directed content analysis.ResultsStatistically significant improvements in anxiety (p = 0.024) and stress (p = 0.017) were observed from baseline to 2-weeks post intervention. Improvements in well-being (p = 0.021), depression (p = 0.031), anxiety (p = 0.005), and stress (p = 0.004) were also observed from baseline to 6-weeks. No statistically significant changes were seen in self-compassion, optimism, or sleep quality. Effect sizes (partial η2s) ranged from 0.25 (depression) to 0.42 (stress). Qualitative feedback comprised of five key themes, namely: factors affecting engagement, issues with functionality, preferences regarding aesthetics, effectiveness and adverse effects, and cultural acceptability.ConclusionsOur preliminary results suggest that Whitu may be an effective app for improving multiple dimensions of young people's well-being. Modifications to the look and feel, cultural content, and onboarding have been undertaken based on the qualitative feedback, and an RCT is currently underway.

Dataset Information

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

Publications

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

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