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Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)
BACKGROUND: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6341752/ https://www.ncbi.nlm.nih.gov/pubmed/30693094 http://dx.doi.org/10.1186/s40814-019-0397-6 |
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author | Hilari, Katerina Behn, Nicholas Marshall, Jane Simpson, Alan Thomas, Shirley Northcott, Sarah Flood, Chris McVicker, Sally Jofre-Bonet, Mireia Moss, Becky James, Kirsty Goldsmith, Kimberley |
author_facet | Hilari, Katerina Behn, Nicholas Marshall, Jane Simpson, Alan Thomas, Shirley Northcott, Sarah Flood, Chris McVicker, Sally Jofre-Bonet, Mireia Moss, Becky James, Kirsty Goldsmith, Kimberley |
author_sort | Hilari, Katerina |
collection | PubMed |
description | BACKGROUND: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. METHODS/DESIGN: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). DISCUSSION: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-019-0397-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6341752 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-63417522019-01-28 Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) Hilari, Katerina Behn, Nicholas Marshall, Jane Simpson, Alan Thomas, Shirley Northcott, Sarah Flood, Chris McVicker, Sally Jofre-Bonet, Mireia Moss, Becky James, Kirsty Goldsmith, Kimberley Pilot Feasibility Stud Study Protocol BACKGROUND: Despite the high prevalence of mood problems after stroke, evidence on effective interventions particularly for those with aphasia is limited. There is a pressing need to systematically evaluate interventions aiming to improve wellbeing for people with stroke and aphasia. This study aims to evaluate the feasibility of a peer-befriending intervention. METHODS/DESIGN: SUPERB is a single blind, parallel group feasibility trial of peer befriending for people with aphasia post-stroke and low levels of psychological distress. The trial includes a nested qualitative study and pilot economic evaluation and it compares usual care (n = 30) with usual care + peer befriending (n = 30). Feasibility outcomes include proportion screened who meet criteria, proportion who consent, rate of consent, number of missing/incomplete data on outcome measures, attrition rate at follow-up, potential value of conducting main trial using value of information analysis (economic evaluation), description of usual care, and treatment fidelity of peer befriending. Assessments and outcome measures (mood, wellbeing, communication, and social participation) for participants and significant others will be administered at baseline, with outcome measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome measures before training and after they have completed two cycles of befriending. The qualitative study will use semi-structured interviews of purposively sampled participants (n = 20) and significant others (n = 10) from both arms of the trial, and all peer befrienders to explore the acceptability of procedures and experiences of care. The pilot economic evaluation will utilise the European Quality of life measure (EQ-5D-5 L) and a stroke-adapted version of the Client Service Receipt Inventory (CSRI). DISCUSSION: This study will provide information on feasibility outcomes and an initial indication of whether peer befriending is a suitable intervention to explore further in a definitive phase III randomised controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02947776, registered 28th October 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-019-0397-6) contains supplementary material, which is available to authorized users. BioMed Central 2019-01-22 /pmc/articles/PMC6341752/ /pubmed/30693094 http://dx.doi.org/10.1186/s40814-019-0397-6 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Hilari, Katerina Behn, Nicholas Marshall, Jane Simpson, Alan Thomas, Shirley Northcott, Sarah Flood, Chris McVicker, Sally Jofre-Bonet, Mireia Moss, Becky James, Kirsty Goldsmith, Kimberley Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title | Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title_full | Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title_fullStr | Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title_full_unstemmed | Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title_short | Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB) |
title_sort | adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for supporting wellbeing through peer befriending (superb) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6341752/ https://www.ncbi.nlm.nih.gov/pubmed/30693094 http://dx.doi.org/10.1186/s40814-019-0397-6 |
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