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Singing for People With Aphasia (SPA)

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Singing group + resource pack
Resource pack
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Exeter

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Resource pack

Singing group + resource pack

Arm Description

Aphasia resource pack

Singing group + Aphasia resource pack

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

Communication Outcome After STroke (COAST)
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
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
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
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
Adverse events used to gauge the safety of the intervention

Full Information

First Posted
February 28, 2017
Last Updated
October 10, 2018
Sponsor
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT03076736
Brief Title
Singing for People With Aphasia
Acronym
SPA
Official Title
Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resource pack
Arm Type
Active Comparator
Arm Description
Aphasia resource pack
Arm Title
Singing group + resource pack
Arm Type
Experimental
Arm Description
Singing group + Aphasia resource pack
Intervention Type
Behavioral
Intervention Name(s)
Singing group + resource pack
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resource pack
Intervention Description
Resource pack with information on living with aphasia and local community activities.
Primary Outcome Measure Information:
Title
ICEpop CAPability measure for Adults (ICECAP-A)
Description
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
Title
Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
Description
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
Title
EQ-5D-5L (health-related quality of life states consisting of five dimensions)
Description
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
Title
modified Reintegration to Normal Living (mRNL)
Description
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
Secondary Outcome Measure Information:
Title
Communication Outcome After STroke (COAST)
Description
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
Title
Very Short Version of the Minnesota Aphasia test
Description
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
Title
Service Receipt Inventory
Description
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
Title
Care related Quality of Life (CarerQoL-7D)48
Description
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
Title
Adverse incidents
Description
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.
Other Pre-specified Outcome Measures:
Title
Recruitment
Description
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
Title
Retention
Description
An assessment of the retention rates in the trial
Time Frame
From Randomisation through study completion, an average of 36 weeks
Title
Qualitative Interviews
Description
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
Title
Intervention fidelity (intervention group only): Singing group attendance
Description
A register of attendance at the singing group
Time Frame
During the intervention, up to 10 weeks
Title
Intervention fidelity (intervention group only): Session adherence
Description
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
Title
Intervention fidelity (intervention group only): Observations
Description
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
Title
Intervention fidelity (intervention group only): Video recordings
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Exeter
City
Exeter
ZIP/Postal Code
EX1 2LU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33441355
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.
Results Reference
derived
PubMed Identifier
30206095
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.
Results Reference
derived

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Singing for People With Aphasia

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