Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Sleep (Actigraph Measurement)
研究概览
简要总结
This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.
详细描述
In community (non-VA) NHs [one from each of 3 national NH corporations], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-funded grant (the R33 phase) to test the impact and sustainability of this intervention for NH residents with ADRD in an incomplete stepped-wedge randomized controlled trial.
THIS PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD THE FOLLOWING SPECIFIC AIMS:
- Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs.
- Test and refine the research methods to: effectively identify eligible NHs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (Fitbits); transfer primary and secondary data to our data center; and merge all data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nursing home residents aged >=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems
排除标准
- •residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
- •residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies
结局指标
主要结局
Sleep (Actigraph Measurement)
时间窗: 15 week sleep intervention period
Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)
次要结局
未报告次要终点
研究者
A. Lynn Snow
Professor
University of Alabama, Tuscaloosa