Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)

Abstract 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 st...

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Main Authors: Katerina Hilari, Nicholas Behn, Jane Marshall, Alan Simpson, Shirley Thomas, Sarah Northcott, Chris Flood, Sally McVicker, Mireia Jofre-Bonet, Becky Moss, Kirsty James, Kimberley Goldsmith
Format: Article
Language:English
Published: BMC 2019-01-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:http://link.springer.com/article/10.1186/s40814-019-0397-6
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author Katerina Hilari
Nicholas Behn
Jane Marshall
Alan Simpson
Shirley Thomas
Sarah Northcott
Chris Flood
Sally McVicker
Mireia Jofre-Bonet
Becky Moss
Kirsty James
Kimberley Goldsmith
author_facet Katerina Hilari
Nicholas Behn
Jane Marshall
Alan Simpson
Shirley Thomas
Sarah Northcott
Chris Flood
Sally McVicker
Mireia Jofre-Bonet
Becky Moss
Kirsty James
Kimberley Goldsmith
author_sort Katerina Hilari
collection DOAJ
description Abstract 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.
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spelling doaj.art-b9824461c72d47969f74b4cc04c6b3052022-12-22T01:23:42ZengBMCPilot and Feasibility Studies2055-57842019-01-015111610.1186/s40814-019-0397-6Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)Katerina Hilari0Nicholas Behn1Jane Marshall2Alan Simpson3Shirley Thomas4Sarah Northcott5Chris Flood6Sally McVicker7Mireia Jofre-Bonet8Becky Moss9Kirsty James10Kimberley Goldsmith11Centre for Language and Communication Science Research, School of Health Sciences, City, University of LondonCentre for Language and Communication Science Research, School of Health Sciences, City, University of LondonCentre for Language and Communication Science Research, School of Health Sciences, City, University of LondonCentre for Mental Health Research, School of Health Sciences, City, University of LondonDivision of Rehabilitation and Ageing, School of Medicine, Floor B, The Medical School, Queen’s Medical Centre, University of NottinghamCentre for Language and Communication Science Research, School of Health Sciences, City, University of LondonCentre for Mental Health Research, School of Health Sciences, City, University of LondonAphasia Re-Connect at City, Centre for Language and Communication Science Research, School of Health Sciences, City, University of LondonDepartment of Economics, School of Arts and Social Sciences, City, University of LondonCentre for Language and Communication Science Research, School of Health Sciences, City, University of LondonBiostatistics & Health Informatics Department, Division of Psychology and Systems Sciences, Institute of Psychiatry, Psychology and Neuroscience, King’s College LondonBiostatistics & Health Informatics Department, Division of Psychology and Systems Sciences, Institute of Psychiatry, Psychology and Neuroscience, King’s College LondonAbstract 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.http://link.springer.com/article/10.1186/s40814-019-0397-6StrokeAphasiaPeer supportPeer befriendingRandomised controlled trialFeasibility
spellingShingle Katerina Hilari
Nicholas Behn
Jane Marshall
Alan Simpson
Shirley Thomas
Sarah Northcott
Chris Flood
Sally McVicker
Mireia Jofre-Bonet
Becky Moss
Kirsty James
Kimberley Goldsmith
Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB)
Pilot and Feasibility Studies
Stroke
Aphasia
Peer support
Peer befriending
Randomised controlled trial
Feasibility
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 Stroke
Aphasia
Peer support
Peer befriending
Randomised controlled trial
Feasibility
url http://link.springer.com/article/10.1186/s40814-019-0397-6
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