Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 6-item Acceptability Scale
研究概览
简要总结
The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥65 years old
- •≤ 7 on the RU-SATED self-report questionnaire
- •MMSE ≥25 and AD8 <3
排除标准
- •Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- •>3 on the STOP BANG indicating increased risk of sleep apnea
- •Evidence of restless legs syndrome on RLS-Diagnosis Index
- •Evidence of circadian rhythm sleep-wake disorder
- •Evidence of parasomnia
- •Regular use (>2x/week) of prescription or over-the-counter medications to improve sleep
- •Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- •Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
- •Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-V criteria
- •History of nervous system disorder such as stroke or Parkinson's disease
- •Severe mental illness such as schizophrenia or bipolar disorder
- •Current or history (within 5 years) of shift work including hours of midnight-4am
- •Is currently receiving a behavioral sleep health intervention
结局指标
主要结局
6-item Acceptability Scale
时间窗: 6 week
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
semi-standardized qualitative interview
时间窗: 6 week
Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes
WHOQOL-BREF
时间窗: baseline, 6 week and 12 week reassessments
The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.
Ru_SATED sleep health composite
时间窗: baseline, 6 week and 12 week reassessments
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires. The domains will be summed to create the composite sleep health score ranging from 0-6 with a higher score indicating better sleep health.
Tilburg Frailty Indicator
时间窗: baseline, 6 week and 12 week reassessments
The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.
次要结局
- Pittsburgh Sleep Quality Index(baseline, 6 week and 12 week reassessments)
- Epworth Sleepiness Scale(baseline, 6 week and 12 week reassessments)
- Dysfunctional Beliefs About Sleep(baseline, 6 week and 12 week reassessments)
- Actigraphy(baseline, 6 week and 12 week reassessments)
- Sleep Self-Efficacy(baseline, 6 week and 12 week reassessments)
研究者
Catherine Siengsukon, PT, PhD
Professor
University of Kansas Medical Center