Singing for People With Aphasia

NCT03076736 | Completed DMC

• 1 other identifier: 1617\014\140293
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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)

Conditions

Aphasia

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  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)

  Measures change from baseline to 6 months post intervention

• Very Short Version of the Minnesota Aphasia test

  Measures change from baseline to 6 months post intervention

• Service Receipt Inventory

  Measures change from baseline to 6 months post intervention

• Care related Quality of Life (CarerQoL-7D)48

  Measures change from baseline to 6 months post intervention

• Adverse incidents

  Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.

Other Outcomes (7)

• Recruitment

  From the start of participant identification through to participant randomisation, over a period of 8 months

• Retention

  From Randomisation through study completion, an average of 36 weeks

• Qualitative Interviews

  Interviews to be conducted 3 months post-intervention

Study Arms (2)

Resource pack

ACTIVE COMPARATOR

Aphasia resource pack

Behavioral: Resource pack

Singing group + resource pack

EXPERIMENTAL

Singing group + Aphasia resource pack

Behavioral: Singing group + resource pack

Interventions

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.

Singing group + resource pack

Resource pack BEHAVIORAL

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

Resource pack

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, EX1 2LU, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33441355 DERIVED

• 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.

  PMID: 30206095 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 10, 2017
• Study Start: June 1, 2017
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)