An interventional study of Singing group + resource pack and Resource pack in Aphasia, sponsored by University of Exeter. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by University of Exeter · Not applicable, Interventional, and Treatment
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)
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.
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's enrollment of 41 is above the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of Exeter is the lead sponsor of 138 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aphasia resource pack
Behavioral: Resource pack
Singing group + Aphasia resource pack
Behavioral: Singing group + resource pack
SPA is a community-based, 10 weekly singing group. Each SPA session comprises 30 minutes of settling in/wrap-up and departure, and 60 minutes of group singing. Sessions will be led by a community music leader, co-facilitated by a person with aphasia, and involve the group singing from a songbook. Musical accompaniment will be provided by the facilitator(s). Small percussion instruments will be available for participants, enabling involvement of those with limited singing ability. Intervention content integrates the Information-Motivation-Behavioural (IMB) skills model of health behaviour change to support individuals in developing the social skills and confidence needed to improve psychosocial outcomes. Participants will also receive the resource pack.
Resource pack with information on living with aphasia and local community activities.
ICEpop CAPability measure for Adults (ICECAP-A)
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.
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
Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
A 39-item health-related quality of life measure with 4 subdomains: physical, psychosocial, communication, and energy.
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
EQ-5D-5L (health-related quality of life states consisting of five dimensions)
A 5-item measure of health-related quality of life (plus EQ-VAS visual analogue scale), that can be used for cost utility analysis.
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
modified Reintegration to Normal Living (mRNL)
An 11-item measure that captures social participation (e.g. recreation, movement in the community, and interaction in family or other relationships).
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
Communication Outcome After STroke (COAST)
A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
Time frame: Measures change from baseline to 6 months post intervention
Very Short Version of the Minnesota Aphasia test
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.
Time frame: Measures change from baseline to 6 months post intervention
Service Receipt Inventory
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.
Time frame: Measures change from baseline to 6 months post intervention
Care related Quality of Life (CarerQoL-7D)48
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.
Time frame: Measures change from baseline to 6 months post intervention
Adverse incidents
Adverse events used to gauge the safety of the intervention
Time frame: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
Recruitment
An assessment of the recruitment to the trial
Time frame: From the start of participant identification through to participant randomisation, over a period of 8 months
Retention
An assessment of the retention rates in the trial
Time frame: From Randomisation through study completion, an average of 36 weeks
Qualitative Interviews
15 Qualitative interviews across the intervention and control groups to discuss individuals' experiences of the trial processes and the intervention. Participants will report on the acceptability of trial and intervention activities
Time frame: Interviews to be conducted 3 months post-intervention
Intervention fidelity (intervention group only): Singing group attendance
A register of attendance at the singing group
Time frame: During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Session adherence
Group facilitators will record which aspects of the intervention manual have been followed during the group session
Time frame: During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Observations
The research team will observe and record the extent to which the group facilitators are following the key elements of the intervention manual and the participants are adhering to facilitator instructions
Time frame: During the intervention, up to 10 weeks
Intervention fidelity (intervention group only): Video recordings
The research team will video-record a selection of singing group sessions to assess facilitator and participant adherence
Time frame: During the intervention, up to 10 weeks
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Exeter