Singing for People With Aphasia (SPA)

October 10, 2018 updated by: University of Exeter

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

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)

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resource pack
Aphasia resource pack
Resource pack with information on living with aphasia and local community activities.
Experimental: Singing group + resource pack
Singing group + Aphasia 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICEpop CAPability measure for Adults (ICECAP-A)
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
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)
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
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)
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
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)
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
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)
Time Frame: Measures change from baseline to 6 months post intervention
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
Time Frame: Measures change from baseline to 6 months post intervention
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
Time Frame: Measures change from baseline to 6 months post intervention
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
Time Frame: Measures change from baseline to 6 months post intervention
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
Time Frame: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
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.

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 27, 2018

Study Completion (Actual)

September 27, 2018

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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