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Adjustment With Aphasia After Stroke: SUPERB

City, University of London · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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aphasianastroke
Aims: This exploratory trial will: 1. Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness of peer-befriending for people with aphasia post-stroke. 2. Investigate psychological and social wellbeing outcomes of participants, significant others, and peer befrienders. 3. Explore the feasibility of a full economic evaluation of usual care + peer befriending versus usual care control. Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care + peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver on four work packages: development phase; RCT; qualitative study; economic evaluation. Participants (n=60) will be assessed three times up to 10 months post-randomisation. Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion screened who meet criteria; proportion who consent; rate of consent); participant, significant other, peer befriender views on acceptability of procedures (qualitative study); 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; treatment fidelity of peer-befriending. Patient-reported outcomes will include mood, wellbeing, communication and social participation. Benefits: Peer befriending may help avert some of the serious psychological consequences of stroke, and prevent the need for more complex and costly psychological therapies.
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