- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057068
Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)
Improving Sleep In Veterans and Their Family Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Evaluations:
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SLEEP-E Dyads Intervention
SLEEP-E Dyads Six-Week Tele-Health 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (T1) and Post-Intervention (T2) - 8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline (T1) and Post-Intervention (T2) - 8 Weeks
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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.
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Baseline (T1) and Post-Intervention (T2) - 8 Weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Patricia C Griffiths, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E7249-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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