Dataset Information

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility.

ABSTRACT:

Objectives

Pilot 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.

Design

A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.

Setting

Three community-based cohorts in the South-West of England.

Participants

Eligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.

Intervention

The 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 measures

Collected 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.

Results

Of 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.

Conclusions

The SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.

Trial registration number

NCT03076736.

SUBMITTER: Tarrant M

PROVIDER: S-EPMC7812101 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility.

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

BMJ open 20210113 1

<h4>Objectives</h4>Pilot 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 intervent ...[more]

PMID: 33441355

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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:OBJECTIVES:To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity. DESIGN:A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations. SETTING:Community settings across two sites in Devon. PARTICIPANTS:Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation. INTERVENTIONS:ReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet. OUTCOME MEASURES:Candidate primary outcomes included functional mobility and physical activity. RESULTS:Forty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations. CONCLUSIONS:All objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable. TRIAL REGISTRATION NUMBER:NCT02429180; Results.

Project description:ObjectivesThe Solution Focused Brief Therapy in Post-Stroke Aphasia feasibility trial had four primary aims: to assess (1) acceptability of the intervention to people with aphasia, including severe aphasia, (2) feasibility of recruitment and retention, (3) acceptability of research procedures and outcome measures, and (4) feasibility of delivering the intervention by speech and language therapists.DesignTwo-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research.SettingParticipants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups).ParticipantsPeople with aphasia at least 6 months post stroke.InterventionSolution-focused brief therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over 3 months, either immediately postrandomisation or after a delay of 6 months.Outcome measuresPrimary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, 3 and 6 months postrandomisation, and at 9 months (wait-list group only). The candidate primary outcome measure was the Warwick-Edinburgh Mental Well-being Scale. Participants and therapists also took part in in-depth interviews.ResultsThirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable by both participants (n=30 interviews) and therapists (n=3 interviews); 93.8% of participants had ≥2 therapy sessions (90.6% had 6/6 sessions). Feasibility endpoints: recruitment target was reached within the prespecified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at 6 months; missing data <0.01%. All five prespecified feasibility progression criteria were met.ConclusionThe high retention and adherence rates, alongside the qualitative data, suggest the study design was feasible and therapy approach acceptable even to people with severe aphasia. These results indicate a definitive randomised controlled trial of the intervention would be feasible.Trial registration numberNCT03245060.

Project description:BackgroundDiabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation.MethodsA pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up.ResultsSeventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up. CONCLUSIONS: The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

Project description:ObjectiveTo determine the feasibility and acceptability of peer-befriending, for people with aphasia.DesignSingle-blind, parallel-group feasibility randomised controlled trial comparing usual care to usual care + peer-befriending.Participants and settingPeople with aphasia post-stroke and low levels of distress, recruited from 5 NHS Hospitals and linked community services; their significant others; and 10 befrienders recruited from community.InterventionSix 1-hour peer-befriending visits over three months.Main measuresFeasibility parameters included proportion eligible of those screened; proportion consented; missing data; consent and attrition rates. Acceptability was explored through qualitative interviews. Outcomes for participants and significant others were measured at baseline, 4- and 10-months; for peer-befrienders before training and after one/two cycles of befriending.ResultsOf 738 patients identified, 75 were eligible of 89 fully screened (84%), 62 consented (83% of eligible) and 56 randomised. Attrition was 16%. Adherence was high (93% attended ⩾2 sessions, 81% all six). The difference at 10 months on the GHQ-12 was 1.23 points on average lower/better in the intervention arm (95% CI 0.17, -2.63). There was an 88% decrease in the odds of GHQ-12 caseness (95% CI 0.01, 1.01). Fourty-eight significant others and 10 peer-befrienders took part. Procedures and outcome measures were acceptable. Serious adverse events were few (n = 10, none for significant others and peer-befrienders) and unrelated.ConclusionsSUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in terms of depression. Peer-befriending is a suitable intervention to explore further in a definitive trial.Clinical trial registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02947776Subject terms: Translational research, mental health, rehabilitation, quality and outcomes, stroke.

Project description:INTRODUCTION:HIV-associated neurocognitive disorder (HAND) may affect 30%-50% of people ageing with HIV. HAND may increase stress and anxiety, and impede coping. Psychosocial group therapy may ameliorate HAND's symptoms, yet the ideal intervention is unclear. This protocol outlines a pilot randomised controlled trial (RCT)-designed using community-based participatory research-to pilot cognitive remediation group therapy (CRGT) against an active comparator. METHODS AND ANALYSIS:This is a pilot, parallel design, two-arm RCT that will recruit participants diagnosed with the mild neurocognitive disorder form of HAND from a neurobehavioural research unit at a tertiary care hospital in Toronto, Canada. Eligibility criteria include age ?40 years, known HIV status for 5+ years, English fluency, able to consent and able to attend 8?weeks of group therapy. Eligible participants will be randomised to one of two treatment arms, each consisting of eight-session group interventions delivered once weekly at 3?hours per session. Arm 1 (novel) is CRGT, combining mindfulness-based stress reduction with brain training activities. Arm 2 (active control) is mutual aid group therapy. The primary outcomes are feasibility, measured by proportions of recruitment and completion, and acceptability, determined by a satisfaction questionnaire. The secondary outcome is intervention fidelity, where content analysis will be used to assess facilitator session reports. A between-group analysis will be conducted on exploratory outcomes of stress, anxiety, coping and use of intervention activities that will be collected at three time points. ETHICS AND DISSEMINATION:Ethical approval was obtained from the Research Ethics Boards of St. Michael's Hospital and the University of Toronto. Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study could provide insight into design (eg, recruitment, measures) and intervention considerations (eg, structure, content) for a larger trial to lessen the burden of cognitive decline among people ageing with HIV. TRIAL REGISTRATION NUMBER:NCT03483740; Pre-results.

Project description:BackgroundDespite the clear benefits of physical activity in healthy ageing, engagement in regular physical activity among community-dwelling older adults remains low, with common barriers including exertional discomfort, concerns with falling, and access difficulties. The recent rise of the use of technology and the internet among older adults presents an opportunity to engage with older people online to promote increased physical activity. This study aims to determine the feasibility and acceptability of training volunteers to deliver online group exercises for older adults attending community social clubs.MethodsThis was a pre-post mixed-methods study. Older adults aged ≥ 65 years attending community social clubs who provided written consent and were not actively participating in exercise classes took part in the feasibility study. Older adults, volunteers, and staff were interviewed to determine the acceptability of the intervention. The intervention was a once weekly volunteer-led online group seated strength exercises using resistance bands. The duration of the intervention was 6 months. The primary outcome measures were the feasibility of the intervention (determined by the number of volunteers recruited, trained, and retained, participant recruitment and intervention adherence) and its acceptability to key stakeholders. Secondary outcome measures included physical activity levels (Community Health Model Activities Programme for Seniors (CHAMPS) questionnaire), modified Barthel Index, Health-related quality of life (EQ-5D-5L), frailty (PRISMA-7) and sarcopenia (SARC-F), at baseline and 6 months.ResultsNineteen volunteers were recruited, 15 (78.9%) completed training and 9 (47.3%) were retained after 1 year (mean age 68 years). Thirty older adults (mean age 77 years, 27 female) participated, attending 54% (IQR 37-67) of exercise sessions. Participants had no significant changes in secondary outcome measures, with a trend towards improvement in physical activity levels (physical activity in minutes per week at baseline was 1770 min, and 1909 min at six months, p = 0.13). Twenty volunteers, older adults, and staff were interviewed and found the intervention acceptable. The seated exercises were perceived as safe, manageable, and enjoyable.ConclusionsTrained volunteers can safely deliver online group exercise for community-dwelling older adults which was acceptable to older adults, volunteers, and club staff.Trials registrationNCT04672200.

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.

Dataset Information

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility.

Objectives

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusions

Trial registration number

Publications

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility.

Similar Datasets

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