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NCT02947776: SUPERB

Adjustment With Aphasia After Stroke: SUPERB

Completed NA Last updated 22 July 2020
What this trial tests

NA trial testing PEER in Stroke in 62 participants. Completed in 20 August 2019.

Timeline
25 May 2017
Primary endpoint
20 August 2019
20 August 2019

Quick facts

Lead sponsorCity, University of London
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment62
Start date25 May 2017
Primary completion20 August 2019
Estimated completion20 August 2019
Sites5 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

City, University of London

Who can join

18 and older, any sex, with Stroke or Aphasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Supporting wellbeing through peer-befriending (SUPERB) for people with aphasia: A feasibility randomised controlled trial.
    Hilari K, Behn N, James K, Northcott S, et al · · 2021 · cited 29× · PMID 33624514 · DOI 10.1177/0269215521995671
  2. Adjustment with aphasia after stroke: study protocol for a pilot feasibility randomised controlled trial for SUpporting wellbeing through PEeR Befriending (SUPERB).
    Hilari K, Behn N, Marshall J, Simpson A, et al · · 2019 · cited 16× · PMID 30693094 · DOI 10.1186/s40814-019-0397-6
  3. Pharmacological, non-invasive brain stimulation and psychological interventions, and their combination, for treating depression after stroke.
    Allida SM, Hsieh CF, Cox KL, Patel K, et al · · 2023 · cited 11× · PMID 37417452 · DOI 10.1002/14651858.cd003437.pub5
  4. "For them and for me": a qualitative exploration of peer befrienders' experiences supporting people with aphasia in the SUPERB feasibility trial.
    Northcott S, Behn N, Monnelly K, Moss B, et al · · 2022 · cited 8× · PMID 34027757 · DOI 10.1080/09638288.2021.1922520
  5. "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.
    Moss B, Behn N, Northcott S, Monnelly K, et al · · 2022 · cited 7× · PMID 34086521 · DOI 10.1080/09638288.2021.1922519
  6. SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia.
    Behn N, Moss B, McVicker S, Roper A, et al · · 2021 · cited 3× · PMID 34341046 · DOI 10.1136/bmjopen-2020-047994
  7. A pilot economic evaluation of a feasibility trial for SUpporting wellbeing through PEeR-Befriending (SUPERB) for post-stroke aphasia.
    Flood C, Behn N, Marshall J, Simpson A, et al · · 2022 · cited 2× · PMID 35108114 · DOI 10.1177/02692155211063554

Verify or expand the search:

Other trials of PEER

Trials testing the same drug.

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other City, University of London trials

Trials by the same sponsor.

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