AphasiaSPANCT03076736
Singing for People With Aphasia
A study testing Singing group + resource pack and Resource pack in people with Aphasia, run by University of Exeter at 1 site in United Kingdom.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Singing group + resource pack and Resource pack
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 27 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Aphasia
- Being tested
- Singing group + resource pack, Resource pack
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing group + resource packBehavioural
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 packBehavioural
Resource pack with information on living with aphasia and local community activities.
| Study group | Role | What they receive |
|---|---|---|
| Resource pack | Active comparator | Aphasia resource pack Receives: Behavioral: Resource pack |
| Singing group + resource pack | Experimental | Singing group + Aphasia resource pack Receives: Behavioral: Singing group + resource pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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 (5)
Communication Outcome After STroke (COAST)
A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measures change from baseline to 6 months post intervention
Adverse incidents
Adverse events used to gauge the safety of the intervention
Measured: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Jun 2017
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076736
- Sponsor's protocol ID
- 1617\014\140293
- Acronym
- SPA
- Status last verified
- Oct 2018
- First submitted
- 28 Feb 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33441355Tarrant 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.
PubMed 30206095
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
- ClinicalTrials.gov ID
- NCT03076736
- Acronym / sponsor ID
- SPA / 1617\014\140293
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resource pack | Active comparator | Behavioral: Resource packAphasia resource pack |
| Singing group + resource pack | Experimental | Behavioral: Singing group + resource packSinging group + Aphasia resource pack |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singing group + resource packSPA 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. | Behavioural | Singing group + resource pack |
| Resource packResource pack with information on living with aphasia and local community activities. | Behavioural | Resource pack |
Primary outcome
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.
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.
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.
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).
5 secondary outcomes
Communication Outcome After STroke (COAST)
Time frame: 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
Service Receipt Inventory
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 33441355Tarrant 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.
- Derived from this study: PubMed 30206095Tarrant 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.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing group + resource pack and Resource pack in people with Aphasia, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076736, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.