A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 672
- 试验地点
- 6
- 主要终点
- Pittsburgh Sleep Quality Index score
研究概览
简要总结
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- 是
入选标准
- •for Patients
- •Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
- •Community-dwelling
- •>1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
- •Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
- •Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
- •Have no severe medical conditions with a life expectancy of less than 6 months
- •Have an eligible caregiver
- •Inclusion Criteria for Caregivers
- •Live with an eligible patient
- •Aged >18 years
- •Is related to the patient as a family member, a significant other, or a friend
- •Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
- •Pittsburgh Sleep Quality Index (PSQI) total score >5
- •Montreal Cognitive Assessment (MoCA) ≥23
- •Can communicate in English
排除标准
- •Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
- •Paid, professional caregivers will also be excluded.
- •If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.
研究组 & 干预措施
In-Person Care2Sleep
In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
干预措施: Care2Sleep (Behavioral)
Telehealth Care2Sleep
Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
干预措施: Care2Sleep (Behavioral)
Sleep Education only
In-person, education on sleep, aging, and dementia but without specific or individualized recommendations
干预措施: Sleep Education (Behavioral)
结局指标
主要结局
Pittsburgh Sleep Quality Index score
时间窗: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.
Sleep efficiency-Actigraphy
时间窗: Change from Baseline Sleep Efficiency at 6 months
Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality
次要结局
- Total score of Center for Epidemiological Study of Depression Scale(Immediately AND 6 months after the last session of the intervention)
- Total score of Zarit Burden Interview(Immediately AND 6 months after the last session of the intervention)
- Levels of inflammatory markers(Immediately AND 6 months after the last session of the intervention)
- Total score of Revised Memory and Behavior Problem Checklist(Immediately AND 6 months after the last session of the intervention)
- Total score of Quality of Life-Alzheimer's Disease Scale(Immediately AND 6 months after the last session of the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) global health score(Immediately AND 6 months after the last session of the intervention)
研究者
Yeonsu Song, PhD, RN, FNP
Assistant Professor
University of California, Los Angeles