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临床试验/NCT03115268
NCT03115268已完成不适用

Delivering Group Support for People With Aphasia Through Eva Park

City, University of London2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)

研究概览

简要总结

The project will investigate the feasibility and acceptability of a remote support group intervention for people with aphasia, and will investigate the impact of that intervention on measures of wellbeing, quality of life and communication. The intervention will be delivered to 32 participants in Eva Park, a virtual island specifically designed for people with aphasia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Stroke survivor with aphasia; Score within the aphasic range on the Frenchay Aphasia Screening Test (FAST); Fluent pre-stroke user of English.

排除标准

  • Co-morbidity affecting cognition; Severe hearing or visual impairments

研究组 & 干预措施

Immediate

Experimental

Participants allocated to the immediate arm will receive 6 months of Social support groups delivered in EVA Park immediately after randomisation. They will be re-assessed in Month 7, then receive 6 months of usual care, followed by reassessment in month 14.

干预措施: Social support groups delivered in EVA Park (Behavioral)

Wait list control

Active Comparator

Participants allocated to the wait list control arm will receive 6 months of usual care after randomisation. They will be re-assessed in month 7, and will then receive 6 months of social support groups delivered in EVA Park, with reassessment in month 14.

干预措施: Social support groups delivered in EVA Park (Behavioral)

结局指标

主要结局

Pre to post intervention change on the Warwick Edinburgh Mental Well-being Scale (WEMWBS)

时间窗: At randomisation and at 7 and 14 months post randomisation

A 14 item questionnaire about feelings of wellbeing

Pre to post intervention change on the Communication Activities of Daily Living test (CADL-2)

时间窗: At randomisation and at 7 and 14 months post randomisation

A 50 item standardized test of everyday communication activities, designed for people with aphasia

次要结局

  • Pre to post intervention change on The Western Aphasia Battery - Revised (Kertesz, 2007)(At randomisation and at 7 and 14 months post randomisation)
  • Pre to post intervention change on the Stroke and Aphasia Quality of Life measure (SAQOL-39) (Hilari et al, 2003)(At randomisation and at 7 and 14 months post randomisation)
  • Pre to post intervention change on the Social Connectedness Scale - Revised (Lee et al. 2001)(At randomisation and at 7 and 14 months post randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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