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Singing for People With Aphasia (SPA)

10 de octubre de 2018 actualizado por: 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)

Descripción general del estudio

Estado

Terminado

Condiciones

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

Intervencionista

Inscripción (Actual)

41

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Exeter, Reino Unido, EX1 2LU
        • University of Exeter

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Comparador activo: Resource pack
Aphasia resource pack
Resource pack with information on living with aphasia and local community activities.
Experimental: Singing group + resource pack
Singing group + Aphasia 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.

¿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
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)
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
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)
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
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)
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
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

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
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

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
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2017

Finalización primaria (Actual)

27 de septiembre de 2018

Finalización del estudio (Actual)

27 de septiembre de 2018

Fechas de registro del estudio

Enviado por primera vez

28 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2017

Publicado por primera vez (Actual)

10 de marzo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre Resource pack

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