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Singing for People With Aphasia (SPA)

10. oktober 2018 opdateret af: 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)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Resource pack
Aphasia resource pack
Adfærdsmæssigt: Resource pack
Resource pack with information on living with aphasia and local community activities.
Eksperimentel: Singing group + resource pack
Singing group + Aphasia resource pack
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICEpop CAPability measure for Adults (ICECAP-A)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Communication Outcome After STroke (COAST)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Exeter

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2017

Primær færdiggørelse (Faktiske)

27. september 2018

Studieafslutning (Faktiske)

27. september 2018

Datoer for studieregistrering

Først indsendt

28. februar 2017

Først indsendt, der opfyldte QC-kriterier

6. marts 2017

Først opslået (Faktiske)

10. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1617\014\140293

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