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Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being.

ABSTRACT: INTRODUCTION:The 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 ANALYSIS:A 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 DISSEMINATION:NHS 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 NUMBER:NCT03076736.

SUBMITTER: Tarrant M

PROVIDER: S-EPMC6144319 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being.

Tarrant Mark M Carter Mary M Dean Sarah Gerard SG Taylor Rod S RS Warren Fiona C FC Spencer Anne A Adamson Jane J Landa Paolo P Code Chris C Calitri Raff R

BMJ open 20180910 9

<h4>Introduction</h4>The 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.<h4>Methods and analysis</h4>A two-group, assessor-blinded, randomised controlled external pilot trial with parallel m ...[more]

PMID: 30206095

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Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:BackgroundPrimary care physicians are particularly prone to high levels of burnout and poor well-being. Despite this, no qualitative studies have specifically investigated the best ways to improve well-being and prevent burnout in primary care physicians. Previous interventions within primary care have been person-oriented and mainly focused on mindfulness, but there has been no prior research on whether general practitioners (GPs) deem this to be the best approach.ObjectivesTo explore strategies that could improve GP well-being and reduce or prevent burnout, based on GP perceptions of the workplace factors that affect their levels of well-being and burnout.MethodsFive focus groups were conducted, with 25 GPs (locums, salaried, trainees, and partners) in the UK, between September 2015 and February 2016. Focus groups took place in GP practices and private meeting rooms. Discussions were centered on the workplace factors that they perceived to influence their well-being, along with strategies that they use either personally, or as a practice, to try and prevent burnout. Furthermore, strategies that could feasibly be implemented by individuals and practices to improve well-being, as well as changes that are needed by groups or organizations that are external to their practice (e.g., the government) to improve the working conditions, were explored. Thematic analysis was conducted on the transcripts.ResultsBased on the contributors to burnout and workplace well-being that the participants identified, the following feasible strategies were suggested: compulsory daily coffee breaks, increasing self- and organizational awareness of the risks of burnout and mentoring or buddy systems. System-level organizational changes were voiced as vital, however, to improve the well-being of all primary care physicians. Increasing resources seemed to be the ideal solution, to allow for more administrative staff and GPs.ConclusionThese strategies merit further consideration by researchers, physicians, healthcare organizations and policy makers both in the UK and beyond. Failure to do so may result in healthcare staff becoming even more burntout, potentially leading to a loss of doctors from the workforce.

Project description:BackgroundPrimary progressive aphasia is a language-led dementia, often associated with frontotemporal dementia. It presents as insidious deterioration of language skills (e.g. naming objects and understanding complex sentences), with relative sparing of cognitive skills initially. There is little research examining the effectiveness of communication skills training for primary progressive aphasia, yet speech and language therapists (SLTs) report regularly using this in clinical practice. 'Better Conversations with Primary Progressive Aphasia' has potential to reduce barriers and increase facilitators to conversation and consequently improve confidence in communication and quality of life for people living with primary progressive aphasia and their conversation partners. The aim of this pilot study is to examine the feasibility of running a trial of the 'Better Conversations with Primary Progressive Aphasia' intervention.MethodsA single blind, randomised controlled pilot study will recruit 42 participants with primary progressive aphasia and their conversation partners across seven UK National Health Service Trusts. Participants will be randomised on a 1:1 basis, stratified by site, to receive either the 'Better Conversations with Primary Progressive Aphasia' intervention (21 couples) or no speech and language therapy treatment (21 couples). Participants are recruited by SLTs who will conduct pre-intervention assessment (week 1) and deliver the intervention (weeks 2 to 5). Junior researchers, who are blinded to allocation, will complete post-intervention measures (week 6). SLTs complete 9 h of training to prepare them to deliver the intervention. The primary objective of the study is to establish for a phase III effectiveness study whether the program can be delivered as intended in a UK National Health Service setting. Specifically, it will establish (1) the acceptability of randomisation, (2) an assessment of treatment fidelity to determine necessary levels of SLT training, (3) the most appropriate primary outcome measure, (4) sample size requirements, (5) predicted patient recruitment and retention rates and (6) refined inclusion criteria.DiscussionInsights from this study will be of relevance to guide development of future research and in particular, trials of therapeutic interventions in PPA, as well as for clinical care for this population.Trial registrationRetrospectively registered 28/02/2018 ISRCTN10148247.

Project description: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.

Project description:About a third of strokes cause aphasia, or language loss, with profound consequences for the person's social participation and quality of life. These problems may be mitigated by group social support. But this intervention is not available to all individuals. This study investigated whether it is feasible to deliver group social support to people with aphasia via a multi-user, virtual reality platform. It also explored the indicative effects of intervention and the costs. Intervention aimed to promote wellbeing and communicative success. It enabled participants to form new social connections and share experiences of living with aphasia. It comprised 14 sessions delivered over 6 months and was led by community based co-ordinators and volunteers. Feasibility measures comprised: recruitment and retention rates, compliance with intervention and assessment of treatment fidelity. Effects of intervention were explored using a waitlist randomised controlled design, with outcome measures of wellbeing, communication, social connectedness and quality of life. Two intervention groups were randomised to an immediate condition and two were randomised to a delayed condition. The main analysis explored scores on the measures between two time points, between which those in the immediate condition had received intervention, but those in the delayed group had not (yet). A comprehensive approach to economic data collection ensured that all costs of treatment delivery were recorded. Feasibility findings showed that the recruitment target was met (N = 34) and 85.3% (29/34) of participants completed intervention. All groups ran the 14 sessions as planned, and participants attended a mean of 11.4 sessions (s.d. 2.8), which was 81.6% of the intended dose. Fidelity checking showed minimal drift from the manualised intervention. No significant change was observed on any of the outcome measures, although the study was not powered to detect these. Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed. The results suggest that a larger trial of remote group support, using virtual reality, would be merited. However the treatment content and regime, and the selection of outcome measures should be reviewed before conducting the trial. Trail registration: Study registered with ClinicalTrials.gov; Identifier: https://www.ncbi.nlm.nih.gov/NCT03115268.

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

Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being.

Publications

Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being.

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