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临床试验/NCT02550392
NCT02550392已完成不适用

Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM)

University of Nottingham1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Number of participants who completed the trial

研究概览

简要总结

Transient Ischaemic Attack (TIA), also called 'ministroke' is characterised by shortlasting symptoms that generally do not cause permanent damage. 'Minor stroke' is a term used to describe a stroke with mild and nondisabling symptoms. TIA and minor stroke patients account for more than half of all cases of stroke and they are at a higher risk to suffer a major stroke. Currently, management of TIA/minor stroke patients is mainly focused on identifying and reducing risk factors for a later stroke. However, people after a TIA often have limited access for further specialist support from stroke-specific rehabilitation services. Although there is variability in the level of recovery and severity of symptoms after TIA and minor stroke, there is evidence that these patients may experience difficulties that affect their quality of life including anxiety and depression.

This study aims to develop, tailor and target the delivery of a time-limited group intervention that offers educational, psychological and social support for people following TIA and minor stroke. A qualitative study (Phase 1) will be conducted with service users and experts working with people with TIA/minor stroke to develop the psychoeducational intervention. Following this, we will conduct a feasibility randomised controlled trial in one centre (Phase 2) to explore whether this group psychoeducational intervention for people after TIA and minor stroke carers is acceptable and to determine the feasibility of the proposed evaluation and the sample size needed in a definite trial.

详细描述

Participants will complete measures at baseline and then randomly allocated to receive the intervention or usual care. The intervention group will receive a group psychoeducational intervention (designed in Phase 1: Qualitative study) in addition to self-help leaflets and usual care. It is anticipated that the intervention will be offered in 6 two-hour sessions over 3 months by an assistant psychologist. The control group will receive usual care plus self-help leaflets on relevant topics. All participants will complete outcome measures at 3 and 6 months after randomisation. We will test the feasibility, tolerability and acceptability of delivering the intervention and will record data on study completion and attrition. Findings will inform the development of a larger trial and will determine if the content and delivery of the intervention meets the needs of people after TIA and minor stroke.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants who completed the trial

时间窗: participants will be followed for the duration of the trial, an expected average of 12 months

Number of participants recruited to the trial

时间窗: up to 1 year

次要结局

  • Knowledge and Satisfaction(baseline, 3 and 6 months follow-up)
  • Mood(baseline, 3 and 6 months follow-up)
  • Health-related Quality of Life(baseline, 3 and 6 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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