- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Exeter, Reino Unido, EX1 2LU
- University of Exeter
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
ICEpop CAPability measure for Adults (ICECAP-A)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Communication Outcome After STroke (COAST)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recruitment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1617\014\140293
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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