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

Sally McVicker¹  Kirsty James²  Kimberley Goldsmith²  Sarah Northcott³  Becky Moss³  Katerina Hilari³  Nicholas Behn³  Jane Marshall³  Alan Simpson⁴  Chris Flood⁴  Mireia Jofre-Bonet⁵  Shirley Thomas⁶ 

[1] Aphasia Re-Connect at City, Centre for Language and Communication Science Research, School of Health Sciences, City, University of London;Biostatistics & Health Informatics Department, Division of Psychology and Systems Sciences, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;Centre for Language and Communication Science Research, School of Health Sciences, City, University of London;Centre for Mental Health Research, School of Health Sciences, City, University of London;Department of Economics, School of Arts and Social Sciences, City, University of London;Division of Rehabilitation and Ageing, School of Medicine, Floor B, The Medical School, Queen’s Medical Centre, University of Nottingham;

关键词: Stroke;    Aphasia;    Peer support;    Peer befriending;    Randomised controlled trial;    Feasibility;   

DOI  :  10.1186/s40814-019-0397-6

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown