Adjustment With Aphasia After Stroke: SUPERB

Summary

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.

Conditions

• Stroke
• Aphasia

Interventions

BEHAVIORAL

PEER

The experimental group will receive usual care + peer befriending. Peer befriending aims to utilise the skills and 'lived experience' of people with longer-term aphasia to offer support to others with aphasia, starting at a time of transition (discharge from hospital and withdrawal of intensive therapeutic input) and increased need. It aims to help people develop their own strategies for adjusting to life post-stroke. Peer-befrienders will visit participants 6 times over a period of 3 months (+2 times within the next 6 months). The schedule, nature of visits, and goals (e.g. discuss concerns; pursue activities) will be agreed between the pair. Visits may include: conversation, problem solving, trips out, joint activities.

BEHAVIORAL

USUAL

The control group will receive usual care, i.e. all health, social care and voluntary services available to them in their borough. It is not known what exactly usual care comprises for people with aphasia who are discharged in the community with low levels of psychological problems, and this project will help to document this.

Sponsors & Collaborators

• City, University of London

  lead OTHER

Principal Investigators

• Katerina Hilari · City, University of London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-25

Primary Completion

2019-08-20

Completion

2019-08-20

Countries

• United Kingdom

Study Locations