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
• Sponsor: VA Office of Research and Development
• Collaborator: Emory University
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sleep Quality	Behavioral: SLEEP-E Dyads Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• 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
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033

Sponsors and Collaborators

VA Office of Research and Development

Emory University

Investigators

• Principal Investigator: Patricia C Griffiths, PhD; Atlanta VA Medical and Rehab Center, Decatur, GA

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02057068
• Other Study ID Numbers: E7249-W
• First Posted: February 6, 2014
• Results First Posted: December 5, 2017
• Last Update Posted: January 23, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:

Caregivers; Telemedicine; Sleep Disorders; Meditation; Cognitive Behavioral Therapy; Activity Enhancement; Technology; Non-pharmacological sleep intervention