Adjustment With Aphasia After Stroke: SUPERB

NCT02947776 | Completed DMC

• 1 other identifier: Staff/16-17/06
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

Aims: This exploratory trial will:

1. 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. 2.Investigate psychological and social wellbeing outcomes of participants, significant others, and peer befrienders.
3. 3.Explore the feasibility of a full economic evaluation of usual care + peer befriending versus usual care control.

Conditions

Stroke; Aphasia

Outcome Measures

Primary Outcomes (4)

• General Health Questionnaire-12 (GHQ-12) continuous total score

  For participants with aphasia.

  4 months post randomisation

• Depression Intensity Scale Circles (DISCS) continuous total score

  The DISCS will be treated as the primary outcome measure only if there is ≥10% missing data in the GHQ-12 due to severity of aphasia, otherwise it will be a secondary outcome measure.

  4 months post randomisation

• General Health Questionnaire-12 (GHQ-12) continuous total score

  For participants with aphasia.

  10 months post randomisation

• Depression Intensity Scale Circles (DISCS) continuous total score

  The DISCS will be treated as the primary outcome measure only if there is ≥10% missing data in the GHQ-12 due to severity of aphasia, otherwise it will be a secondary outcome measure.

  10 months post randomisation

Secondary Outcomes (16)

• Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS) continuous total score.

  4 months post randomisation

• Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS) continuous total score.

  10 months post randomisation

• Communicative Participation Item Bank (CPIB) continuous total score

  4 months post randomisation

• Communicative Participation Item Bank (CPIB) continuous total score

  10 months post randomisation

• Community Integration Questionnaire (CIQ) continuous total score

  4 months post randomisation

Other Outcomes (8)

• Communication Confidence Rating Scale for people with aphasia (CCRSA)

  4 months post randomisation

• Communication Confidence Rating Scale for people with aphasia (CCRSA)

  10 months post randomisation

• Friendship Scale (FS)

  4 months post randomisation

Study Arms (2)

USUAL

ACTIVE COMPARATOR

Usual care

Behavioral: USUAL

PEER

EXPERIMENTAL

Usual care + peer-befriending

Behavioral: PEER; Behavioral: USUAL

Interventions

PEER BEHAVIORAL

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.

PEER

USUAL BEHAVIORAL

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.

PEER; USUAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with aphasia:
• Over 18;
• Fluent premorbid users of English (confirmed by relative or self report);
• Presence of aphasia due to stroke; and
• Low levels of emotional distress (score of ≤2 on Depression Intensity Scale Circles). The latter will ensure that they do not require immediate level 2 or 3 psychological input. People who score 2 (which is also the median on DISCS) and who the MDT deems do not need stepping up or stepping up is not available, will still be eligible to take part.
• Significant Others: each participant with aphasia will nominate one significant other, who is their closest confidant and who is over 18 years of age. If participants live alone their significant other should be someone that they see at least once a week.
• Peer befrienders: will be people with mild-moderate aphasia (score score a minimum 5/10 for auditory comprehension and 5/10 for verbal expression in the Frenchay Aphasia Screening Test) who are over 18 years of age, are at least one year post-stroke

You may not qualify if:

• Participants will be excluded if they have:
• Other diagnoses affecting cognition or mental health (based on medical records for participants with aphasia and self-report for significant others and peer befrienders, as well as the GHQ-12 as a depression screen for peer befrienders: will be excluded if they score 3 or more);
• Severe uncorrected visual or hearing problems (based on medical records for participants with aphasia and self-report for significant others and peer befrienders);
• Severe or potentially terminal co-morbidities, on grounds of frailty (based on medical records for participants with aphasia and self-report for significant others and peer befrienders).
• Participants with aphasia will also be excluded if they are:
• Discharged to a geographical location outside the borough of the recruiting hospital.

Sponsors & Collaborators

• City, University of London: lead

Study Sites (5)

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

The Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Related Publications (5)

• Hilari K, Behn N, Marshall J, Simpson A, Thomas S, Northcott S, Flood C, McVicker S, Jofre-Bonet M, Moss B, James K, Goldsmith K. Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB). Pilot Feasibility Stud. 2019 Jan 22;5:14. doi: 10.1186/s40814-019-0397-6. eCollection 2019.

  PMID: 30693094 BACKGROUND

• Behn N, Moss B, McVicker S, Roper A, Northcott S, Marshall J, Thomas S, Simpson A, Flood C, James K, Goldsmith K, Hilari K. SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia. BMJ Open. 2021 Aug 2;11(8):e047994. doi: 10.1136/bmjopen-2020-047994.

  PMID: 34341046 DERIVED

• Moss B, Behn N, Northcott S, Monnelly K, Marshall J, Simpson A, Thomas S, McVicker S, Goldsmith K, Flood C, Hilari K. "Loneliness can also kill:" a qualitative exploration of outcomes and experiences of the SUPERB peer-befriending scheme for people with aphasia and their significant others. Disabil Rehabil. 2022 Sep;44(18):5015-5024. doi: 10.1080/09638288.2021.1922519. Epub 2021 Jun 4.

  PMID: 34086521 DERIVED

• Northcott S, Behn N, Monnelly K, Moss B, Marshall J, Thomas S, Simpson A, McVicker S, Flood C, Goldsmith K, Hilari K. "For them and for me": a qualitative exploration of peer befrienders' experiences supporting people with aphasia in the SUPERB feasibility trial. Disabil Rehabil. 2022 Sep;44(18):5025-5037. doi: 10.1080/09638288.2021.1922520. Epub 2021 May 23.

  PMID: 34027757 DERIVED

• Hilari K, Behn N, James K, Northcott S, Marshall J, Thomas S, Simpson A, Moss B, Flood C, McVicker S, Goldsmith K. Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial. Clin Rehabil. 2021 Aug;35(8):1151-1163. doi: 10.1177/0269215521995671. Epub 2021 Feb 24.

  PMID: 33624514 DERIVED

Related Links

• Full text of SUPERB protocol paper available on link above

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katerina Hilari

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 28, 2016
• Study Start: May 25, 2017
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (5)