Singing for People With Aphasia

Aphasia Clinical Trial

— SPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076736
• Other study ID #: 1617\014\140293
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 27, 2018

Study information

• Verified date: October 2018
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

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
Resource pack with information on living with aphasia and local community activities.

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter

Sponsors (1)

Lead Sponsor	Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recruitment	An assessment of the recruitment to the trial	From the start of participant identification through to participant randomisation, over a period of 8 months
Other	Retention	An assessment of the retention rates in the trial	From Randomisation through study completion, an average of 36 weeks
Other	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	Interviews to be conducted 3 months post-intervention
Other	Intervention fidelity (intervention group only): Singing group attendance	A register of attendance at the singing group	During the intervention, up to 10 weeks
Other	Intervention fidelity (intervention group only): Session adherence	Group facilitators will record which aspects of the intervention manual have been followed during the group session	During the intervention, up to 10 weeks
Other	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	During the intervention, up to 10 weeks
Other	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	During the intervention, up to 10 weeks
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.