Paradoxical Lucidity in Severe End-Stage Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Phase I - Number of families who express interest in the study and contact the research team
研究概览
简要总结
Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%
- •Accepted for hospice care based on the Medicare eligibility guidelines
- •No longer being provided with nutrition or fluids
- •Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period
排除标准
- •Cognitive or functional impairment due to a diagnosis other than dementia
- •Dementia with a GDS score <7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.
结局指标
主要结局
Phase I - Number of families who express interest in the study and contact the research team
时间窗: up to Day 7
Phase I - Number of self-reports of informants' distress or discomfort due to the presence of the video EEG device.
时间窗: up to Day 7
Phase I - Number of diary reports completed and returned to research staff
时间窗: up to Day 7
Phase I - Total number of instances in which video EEG monitoring was successfully initiated
时间窗: up to Day 7
Phase I - Number of days taken for patients to die after being identified by hospice staff with a life expectancy </= 7 days
时间窗: up to Day 7
Phase I and II - Number of self-reports of patient distress/discomfort in relation to symptom diary use and recording of potential episodes of paradoxical lucidity (PL) using mobile devices
时间窗: up to Day 7
Phase I - Number of successful informed consents obtained from family members/legally authorized health care proxies
时间窗: up to Day 7
Phase I - Time taken to establish video EEG monitoring in homes or nursing homes
时间窗: up to Day 7
Phase I - Average number of days for which video EEG monitoring was completed
时间窗: up to Day 7
次要结局
- Phase II - Average number of changes in EEG rhythm during PL(Baseline, up to Day 7)
- Phase II - Change in average number of changes in EEG rhythm(Baseline, up to Day 7)