| Title: |
Singing for People with Aphasia (SPA): A Protocol for a Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing |
| Authors: |
Tarrant, M; Carter, M; Dean, S; Taylor, R; Warren, F; Spencer, A; Adamson, J; Landa, P; Code, C; Calitri, RA |
| Publisher Information: |
BMJ Publishing Group |
| Publication Year: |
2018 |
| Collection: |
University of Exeter: Open Research Exeter (ORE) |
| Subject Terms: |
Aphasia; Stroke; Group Processes; Rehabilitation Medicine; Clinical Trials |
| Description: |
This is the author accepted manuscript. The final version is available from BMJ Publishing Group via the DOI in this record. ; 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; ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
Published online 10 October 2018.; http://hdl.handle.net/10871/33639; BMJ Open |
| DOI: |
10.1136/bmjopen-2018-025167 |
| Availability: |
http://hdl.handle.net/10871/33639; https://doi.org/10.1136/bmjopen-2018-025167 |
| 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/. |
| Accession Number: |
edsbas.4C66521E |
| Database: |
BASE |