Improving Sleep In Veterans and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Subjective Sleep Quality
研究概览
简要总结
This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the study was to develop and field test non-pharmacological, technology enhanced sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving dyads.The conceptual framework of the intervention incorporated components of cognitive behavioral therapy, psycho-education and self-management support for individuals with chronic conditions with an emphasis on cultivating competence and mastery.
详细描述
Research Plan:
Sample. Veteran care receivers(CR s) or carepartners (CP) over the age of 60 who require assistance from a spousal or cohabitating caregiver (CG) and Veteran caregivers providing care for a cohabitating carepartner were recruited. Dyads underwent comprehensive baseline assessments consisting of in-person home-based interviews and iPad training (T1) followed by a week-long data collection of contemporaneous actigraphic sleep parameters and twice daily (morning and evening) indices of subjective sleep, activity, mood, behavior and sleep hygiene completed on the Tonic for Health Platform. Dyads were randomly assigned to an immediate intervention or wait-list control group. The immediate group received the intervention described below followed by post-intervention assessments (T2) identical to baseline. Wait-list participants then received the intervention followed by a final post-intervention assessment for the wait-list group only (T3).
Intervention.
Daily Videos: Video modules were delivered daily to the dyads' iPads during the 6-week intervention. All participants received core programming of sleep hygiene education, and guided instruction for daily physical activity enhancement "Move-Out!" and meditation/relaxation/self-care "Stand Down!" sessions individualized to functional ability levels. The baseline data allowed for subsequent compilation and programming of individualized, algorithmically derived, adaptive prescriptions for relevant video modules, sleep hygiene recommendations and cognitive behavioral strategies based upon the three independent streams of objective and subjective data for each dyad member. During the intervention dyads completed brief morning and evening diaries to assess compliance with the intervention and capture daily mood and sleep/sleep hygiene data.
Tele-Video-Conferences: Each dyad participated in two tele-video conferences with the PI. The first was to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call was a check-in, encouragement, reinforcement and coaching call. Dyads were re-assessed following the 6-week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This efficacy study was not blinded.
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
- •Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
- •have a life expectancy of greater than or equal to six (6) months,
- •have no plans for transitioning out of home in the next six months,
- •and have approval from the primary care provider to participate in the research.
- •Caregivers must live with care recipient
- •Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.
- •Caregiver can be any age.
- •For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.
排除标准
- •Parkinson's with tremor or other movement disorder that would invalidate actigraphy
- •Untreated diagnosis of sleep apnea or restless leg syndrome
- •Inability to tolerate actigraphy
- •CG and CR sleep efficiency > 85% and/or both members of dyad report sleeping well
- •Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent
研究组 & 干预措施
SLEEP-E Dyads Intervention
SLEEP-E Dyads Six-Week Tele-Health Intervention
- . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.
- . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.
- . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).
- . SLEEP-E Dyads book
- . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching
干预措施: SLEEP-E Dyads Intervention (Behavioral)
Usual Care Group
During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
结局指标
主要结局
Subjective Sleep Quality
时间窗: Baseline (T1) and Post-Intervention (T2) - 8 Weeks
Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score \> 5 (some evidence for 8) is indicative of poor sleep quality.
次要结局
- BEF-SHI Total Number of Negative Sleep Hygiene Behaviors(Baseline (T1) and Post-Intervention (T2) - 8 Weeks)
- Mean Sleep Efficiency(Baseline (T1) and Post-Intervention (T2) - 8 Weeks)