dc.contributor.author | Tarrant, M | |
dc.contributor.author | Carter, M | |
dc.contributor.author | Dean, S | |
dc.contributor.author | Taylor, R | |
dc.contributor.author | Warren, F | |
dc.contributor.author | Spencer, A | |
dc.contributor.author | Adamson, J | |
dc.contributor.author | Landa, P | |
dc.contributor.author | Code, C | |
dc.contributor.author | Calitri, RA | |
dc.date.accessioned | 2018-08-01T15:21:16Z | |
dc.date.issued | 2018-10-22 | |
dc.description.abstract | Introduction: The SPA intervention aims to improve quality of life and wellbeing for people with post-stroke 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 post randomisation 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% confidence intervals 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 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. | en_GB |
dc.description.sponsorship | We would like to thank the Stroke Association for funding this pilot RCT. We are very grateful for PenCLAHRC for their support of the study and to the Peninsula Patient Involvement Group for helping guide the trial design. We would also like to thank Plymouth Music Zone (PMZ) for their support of the study. PMZ was involved in the early development work including intervention design and they will provide resource (staff and facilities) to support the delivery of the intervention. We would also like to thank our SUG for their contributions to the design and development of the research study. The trial is funded by the Stroke Association (QQ12 / TSA 2016/14). Excess treatment costs have been covered by South Devon and Torbay Clinical Commissioning Group, North East and West Devon Clinical Commissioning group, and the University of Exeter Medical School. This research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. We also acknowledge the support of the NIHR Clinical Research Network. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. | en_GB |
dc.identifier.citation | Published online 10 October 2018. | en_GB |
dc.identifier.doi | 10.1136/bmjopen-2018-025167 | |
dc.identifier.uri | http://hdl.handle.net/10871/33639 | |
dc.language.iso | en | en_GB |
dc.publisher | BMJ Publishing Group | en_GB |
dc.rights | © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | |
dc.subject | Aphasia | en_GB |
dc.subject | Stroke | en_GB |
dc.subject | Group Processes | en_GB |
dc.subject | Rehabilitation Medicine | en_GB |
dc.subject | Clinical Trials | en_GB |
dc.title | Singing for People with Aphasia (SPA): A Protocol for a Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing | en_GB |
dc.type | Article | en_GB |
dc.identifier.issn | 2044-6055 | |
dc.description | This is the author accepted manuscript. The final version is available from BMJ Publishing Group via the DOI in this record. | en_GB |
dc.identifier.journal | BMJ Open | en_GB |