Singing for People With Aphasia (SPA)
2018年10月10日 更新者：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)
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
41
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Exeter、英国、EX1 2LU
- University of Exeter
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ICEpop CAPability measure for Adults (ICECAP-A)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Communication Outcome After STroke (COAST)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月1日
初级完成 (实际的)
2018年9月27日
研究完成 (实际的)
2018年9月27日
研究注册日期
首次提交
2017年2月28日
首先提交符合 QC 标准的
2017年3月6日
首次发布 (实际的)
2017年3月10日
研究记录更新
最后更新发布 (实际的)
2018年10月11日
上次提交的符合 QC 标准的更新
2018年10月10日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.