Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)
|ClinicalTrials.gov Identifier: NCT02057068|
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : December 5, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment|
|Sleep Quality||Behavioral: SLEEP-E Dyads Intervention|
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).
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.
Standardized quantitative evaluations regarding the utility of the program were completed following the post-intervention assessments on the iPads. A sub-sample of dyads also participated in qualitative interviews.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Randomization to an immediate intervention group or a no-contact wait list control group. Following post intervention assessments the wait-list control group received the intervention.|
|Masking:||None (Open Label)|
|Masking Description:||This efficacy study was not blinded.|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Sleep In Veterans and Their Family Caregivers|
|Actual Study Start Date :||November 2014|
|Primary Completion Date :||June 2016|
|Study Completion Date :||July 2016|
Experimental: SLEEP-E Dyads Intervention
SLEEP-E Dyads Six-Week Tele-Health Intervention
Behavioral: SLEEP-E Dyads Intervention
Described in arm/group description
No Intervention: Usual Care Group
During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.
- Subjective Sleep Quality [ Time Frame: 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.
- Mean Sleep Efficiency [ Time Frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks ]Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep.
- BEF-SHI Total Number of Negative Sleep Hygiene Behaviors [ Time Frame: Baseline (T1) and Post-Intervention (T2) - 8 Weeks ]Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057068
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||Patricia C Griffiths, PhD||Atlanta VA Medical and Rehab Center, Decatur, GA|