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Singing for People With Aphasia (SPA)

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ClinicalTrials.gov Identifier: NCT03076736
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Exeter

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)

Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Singing group + resource pack Behavioral: Resource pack Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 27, 2018
Actual Study Completion Date : September 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Active Comparator: Resource pack
Aphasia resource pack
Behavioral: Resource pack
Resource pack with information on living with aphasia and local community activities.

Experimental: Singing group + resource pack
Singing group + Aphasia resource pack
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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


Other Outcome Measures:
  1. 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

  2. Retention [ Time Frame: From Randomisation through study completion, an average of 36 weeks ]
    An assessment of the retention rates in the trial

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076736


Locations
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United Kingdom
University of Exeter
Exeter, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03076736     History of Changes
Other Study ID Numbers: 1617\014\140293
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms