Clinical Trial: Singing for People With Aphasia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing

Brief Summary: To undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical and cost effectiveness of SPA for people with aphasia)

Detailed Summary:

Beyond language function, people with aphasia (PWA) report a range of health problems which negatively affect wellbeing, including reduced confidence and social isolation. These psychosocial outcomes of aphasia are not sufficiently met by healthcare services: improvements in language function do not appear to lead to improvements in wellbeing. National clinical guidelines for stroke reflect this observation and highlight the need for community integration and participation of people with aphasia. This research is about singing groups for people with aphasia (SPA) and is intended to address this need by focusing on the wellbeing and social participation needs of people with aphasia after stroke.

The Investigators engagement activities and early development project provided strong impetus for the proposed study: people with aphasia repeatedly told the investigators that singing in groups may help the participants to reconnect with society, and that this will improve wellbeing.

The investigators have planned a pilot study that will allow an assessment of the extent to which the study processes and the singing groups themselves are feasible to run and are acceptable to participants. The information from this work will help the investigators to decide whether to conduct a larger randomised controlled trial (RCT) which would be a fair test of whether SPA can improve the lives of individuals with post stroke aphasia.


Sponsor: University of Exeter

Current Primary Outcome:

  • ICEpop CAPability measure for Adults (ICECAP-A) [ Time Frame: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention ]
    A 5-item measure of capability for the general adult (18+) population for use in economic evaluation. It focuses on wellbeing and comprises five attributes: Attachment, Stability, Achievement, Enjoyment, Autonomy.
  • Stroke and Aphasia Quality of Life Scale (SAQOL - 39) [ Time Frame: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention ]
    A 39-item health-related quality of life measure with 4 subdomains: physical, psychosocial, communication, and energy.
  • EQ-5D-5L (health-related quality of life states consisting of five dimensions) [ Time Frame: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention ]
    A 5-item measure of health-related quality of life (plus EQ-VAS visual analogue scale), that can be used for cost utility analysis.
  • modified Reintegration to Normal Living (mRNL) [ Time Frame: Measures change from baseline to 3 months post intervention, change from baseline to 6 months post intervention, and change from 3 months to 6 months post intervention ]
    An 11-item measure that captures social participation (e.g. recreation, movement in the community, and interaction in fam

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Communication Outcome After STroke (COAST) [ Time Frame: Measures change from baseline to 6 months post intervention ]
      A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
    • Very Short Version of the Minnesota Aphasia test [ Time Frame: Measures change from baseline to 6 months post intervention ]
      A diagnostic tool to identify aphasia type. Comprised of 4 activities: Identifying names, oral reading words, naming pictures, and written spelling. Audio-recorded to allow for diagnosis of aphasia severity.
    • Service Receipt Inventory [ Time Frame: Measures change from baseline to 6 months post intervention ]
      Record of types and amount of use of health and social care resources including clinical contacts, formal and informal social care. Completed by Assessor drawing on participant and family accounts.
    • Care related Quality of Life (CarerQoL-7D)48 [ Time Frame: Measures change from baseline to 6 months post intervention ]
      For completion by carers. A 7-item measures of the impact of providing informal care on carers. Utility tariffs to calculate a weighted sum score of the CarerQol-7D are also available.
    • Adverse incidents [ Time Frame: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention. ]
      Adverse events used to gauge the safety of the intervention


    Original Secondary Outcome: Same as current

    Information By: University of Exeter

    Dates:
    Date Received: February 28, 2017
    Date Started: May 1, 2017
    Date Completion: December 31, 2018
    Last Updated: March 6, 2017
    Last Verified: March 2017