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

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, 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

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.

Keywords: Aphasia; Behavioural intervention; Feasibility; Peer befriending; Peer support; Randomised controlled trial; Stroke.

Conflict of interest statement

The study received full ethics approval from NHS Health Research Authority London Bloomsbury Research Ethics Committee (ref: 16/LO/2187). Local NHS Research and Development approvals were also gained from all participating sites. Informed consent will be obtained from all participants.Not applicableThe authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT diagram of recruitment and participation for people with aphasia
Fig. 2
Fig. 2
CONSORT diagram of recruitment and participation for peer befrienders

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