Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Implementability (feasibility, fidelity and acceptability)
研究概览
简要总结
The Investigators are running a small, early-phase research study across several hospitals in Melbourne, Australia. The study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. The goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group.
This process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. The Investigators will look at how well this approach works in practice, including how easy it is to use, whether it's done consistently, and how acceptable it is to participants.
At the same time, the Investigators will also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. This pilot study will prepare for larger studies in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 55 years.
- •Within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis or for those for whom recruitment <1 month of stroke is not possible they may be recruited to participate within 3-months of stroke
排除标准
- •Severe, intercurrent or progressive illness likely to EITHER
- •Have a prognosis for survival under 24 months; OR
- •In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)
- •Major psychiatric condition requiring medical intervention
研究组 & 干预措施
Young adult stroke survivors (age 18 to 55 inclusive)
干预措施: Observational Cohort (Other)
结局指标
主要结局
Implementability (feasibility, fidelity and acceptability)
时间窗: From enrolment to the six month assessment visit
Evaluation of the implementability will include assessment of the protocol's: * Feasibility, e.g. * Recruitment rate * Retention * Proportion of participants screened that enrolled * Safety via adverse events * Fidelity, e.g. * Proportion of assessments attended * Proportion of data collected and biobanked or analysed * Acceptability, e.g. o Participant acceptability surveys
次要结局
- Fatigue Severity Scale(6 months)
- Visual Analogue Scale to Assess Fatigue (VAS-F)(Assessment at <1, 3- and 6-months post stroke)
- Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue(6 months)
- Cognitive Assessment(6 months)
- modified Rankin Scale (mRS)(6 months)
- 10 metre walk test (10mWT)(6 months)
- Visual Analogue Scale of the Impact of Fatigue on Communication Ability(6 months)