Singing for People With Aphasia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aphasia

Intervention / Treatment
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* Behavioral: Singing group + resource pack
* Behavioral: Resource pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resource pack<br>Aphasia resource pack | Behavioral: Resource pack<br>* Resource pack with information on living with aphasia and local community activities.<br>|
| Experimental: Singing group + resource pack<br>Singing group + Aphasia resource pack | Behavioral: Singing group + resource pack<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication Outcome After STroke (COAST) | A 20-item measure of communication effectiveness for people with any type of communication problem following stroke | 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. | 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. | 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. | Measures change from baseline to 6 months post intervention | 
| Adverse incidents | Adverse events used to gauge the safety of the intervention | Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention. |