- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03076736
Singing for People With Aphasia (SPA)
Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Exeter, Egyesült Királyság, EX1 2LU
- University of Exeter
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: Resource pack
Aphasia resource pack
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Resource pack with information on living with aphasia and local community activities.
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Kísérleti: Singing group + resource pack
Singing group + Aphasia resource pack
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
ICEpop CAPability measure for Adults (ICECAP-A)
Időkeret: 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
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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.
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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
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Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
Időkeret: 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
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A 39-item health-related quality of life measure with 4 subdomains: physical, psychosocial, communication, and energy.
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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
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EQ-5D-5L (health-related quality of life states consisting of five dimensions)
Időkeret: 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
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A 5-item measure of health-related quality of life (plus EQ-VAS visual analogue scale), that can be used for cost utility analysis.
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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
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modified Reintegration to Normal Living (mRNL)
Időkeret: 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
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An 11-item measure that captures social participation (e.g.
recreation, movement in the community, and interaction in family or other relationships).
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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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Communication Outcome After STroke (COAST)
Időkeret: Measures change from baseline to 6 months post intervention
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A 20-item measure of communication effectiveness for people with any type of communication problem following stroke
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Measures change from baseline to 6 months post intervention
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Very Short Version of the Minnesota Aphasia test
Időkeret: Measures change from baseline to 6 months post intervention
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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.
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Measures change from baseline to 6 months post intervention
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Service Receipt Inventory
Időkeret: Measures change from baseline to 6 months post intervention
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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.
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Measures change from baseline to 6 months post intervention
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Care related Quality of Life (CarerQoL-7D)48
Időkeret: Measures change from baseline to 6 months post intervention
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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.
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Measures change from baseline to 6 months post intervention
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Adverse incidents
Időkeret: Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
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Adverse events used to gauge the safety of the intervention
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Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Recruitment
Időkeret: From the start of participant identification through to participant randomisation, over a period of 8 months
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An assessment of the recruitment to the trial
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From the start of participant identification through to participant randomisation, over a period of 8 months
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Retention
Időkeret: From Randomisation through study completion, an average of 36 weeks
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An assessment of the retention rates in the trial
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From Randomisation through study completion, an average of 36 weeks
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Qualitative Interviews
Időkeret: Interviews to be conducted 3 months post-intervention
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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
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Interviews to be conducted 3 months post-intervention
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Intervention fidelity (intervention group only): Singing group attendance
Időkeret: During the intervention, up to 10 weeks
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A register of attendance at the singing group
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During the intervention, up to 10 weeks
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Intervention fidelity (intervention group only): Session adherence
Időkeret: During the intervention, up to 10 weeks
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Group facilitators will record which aspects of the intervention manual have been followed during the group session
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During the intervention, up to 10 weeks
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Intervention fidelity (intervention group only): Observations
Időkeret: During the intervention, up to 10 weeks
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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
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During the intervention, up to 10 weeks
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Intervention fidelity (intervention group only): Video recordings
Időkeret: During the intervention, up to 10 weeks
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The research team will video-record a selection of singing group sessions to assess facilitator and participant adherence
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During the intervention, up to 10 weeks
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 1617\014\140293
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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