Clinical trial NCT03076736: Singing for People With Aphasia
Official title: Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of aphasia after stroke
* Willingness to be randomised to either control or SPA (and able to attend the singing venue)
* Conversational English speaker pre-morbidly
* Capacity to consent (assessed by recruiting team using standard tools)

Exclusion Criteria:

* \<18 years old
* Currently engaged in a speech or language therapy programme
* Intention to relocate outside the geographical region during the study
* Current participation in another study involving a lifestyle intervention
* Currently attending a singing/music group

Primary outcomes:
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: 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
measure: Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
timeFrame: 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
measure: EQ-5D-5L (health-related quality of life states consisting of five dimensions)
timeFrame: 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
measure: modified Reintegration to Normal Living (mRNL)
timeFrame: 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
Secondary outcomes:
measure: Communication Outcome After STroke (COAST)
timeFrame: Measures change from baseline to 6 months post intervention
measure: Very Short Version of the Minnesota Aphasia test
timeFrame: Measures change from baseline to 6 months post intervention
measure: Service Receipt Inventory
timeFrame: Measures change from baseline to 6 months post intervention
measure: Care related Quality of Life (CarerQoL-7D)48
timeFrame: Measures change from baseline to 6 months post intervention
measure: Adverse incidents
timeFrame: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
Other outcomes:
measure: Recruitment
timeFrame: From the start of participant identification through to participant randomisation, over a period of 8 months
measure: Retention
timeFrame: From Randomisation through study completion, an average of 36 weeks
measure: Qualitative Interviews
timeFrame: Interviews to be conducted 3 months post-intervention
measure: Intervention fidelity (intervention group only): Singing group attendance
timeFrame: During the intervention, up to 10 weeks
measure: Intervention fidelity (intervention group only): Session adherence
timeFrame: During the intervention, up to 10 weeks
measure: Intervention fidelity (intervention group only): Observations
timeFrame: During the intervention, up to 10 weeks
measure: Intervention fidelity (intervention group only): Video recordings
timeFrame: During the intervention, up to 10 weeks
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
citation: Tarrant M, Carter M, Dean SG, Taylor R, Warren FC, Spencer A, Adamson J, Landa P, Code C, Backhouse A, Lamont RA, Calitri R. Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility. BMJ Open. 2021 Jan 13;11(1):e040544. doi: 10.1136/bmjopen-2020-040544.
citation: Tarrant M, Carter M, Dean SG, Taylor RS, Warren FC, Spencer A, Adamson J, Landa P, Code C, Calitri R. Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being. BMJ Open. 2018 Sep 10;8(9):e025167. doi: 10.1136/bmjopen-2018-025167.