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Completed

NCT Number: NCT03076736

Singing for People With Aphasia

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)

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Key information

Conditions

Aphasia Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, EX1 2LU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Singing group + resource pack

Behavioral

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

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study title

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

Acronym: SPA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 10, 2017
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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