Singing for People With Aphasia (SPA)
10 octobre 2018 mis à jour par: 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)
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
41
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Exeter, Royaume-Uni, EX1 2LU
- University of Exeter
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ICEpop CAPability measure for Adults (ICECAP-A)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Communication Outcome After STroke (COAST)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2017
Achèvement primaire (Réel)
27 septembre 2018
Achèvement de l'étude (Réel)
27 septembre 2018
Dates d'inscription aux études
Première soumission
28 février 2017
Première soumission répondant aux critères de contrôle qualité
6 mars 2017
Première publication (Réel)
10 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1617\014\140293
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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