Singing for People With Aphasia (SPA): A Pilot Randomised Controlled Trial of a Group Singing Intervention to Improve Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- ICEpop CAPability measure for Adults (ICECAP-A)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •<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
研究组 & 干预措施
Resource pack
Aphasia resource pack
干预措施: Resource pack (Behavioral)
Singing group + resource pack
Singing group + Aphasia resource pack
干预措施: Singing group + resource pack (Behavioral)
结局指标
主要结局
ICEpop CAPability measure for Adults (ICECAP-A)
时间窗: 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.
Stroke and Aphasia Quality of Life Scale (SAQOL - 39)
时间窗: 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.
EQ-5D-5L (health-related quality of life states consisting of five dimensions)
时间窗: 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.
modified Reintegration to Normal Living (mRNL)
时间窗: 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).
次要结局
- Communication Outcome After STroke (COAST)(Measures change from baseline to 6 months post intervention)
- Very Short Version of the Minnesota Aphasia test(Measures change from baseline to 6 months post intervention)
- Service Receipt Inventory(Measures change from baseline to 6 months post intervention)
- Care related Quality of Life (CarerQoL-7D)48(Measures change from baseline to 6 months post intervention)
- Adverse incidents(Measured continuously throughout the intervention (for the intervention group only) and also (for all participants) at 3months and 6months post intervention.)