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Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02057068
First Posted: February 6, 2014
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Sleep Quality Behavioral: SLEEP-E Dyads Intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 102
Actual Study Start Date: November 2014
Study Completion Date: July 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLEEP-E Dyads Intervention

SLEEP-E Dyads Six-Week Tele-Health Intervention

  1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.
  2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise.
  3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care).
  4. . SLEEP-E Dyads book
  5. . 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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057068


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     History of Changes
Other Study ID Numbers: E7249-W
First Submitted: January 24, 2014
First Posted: February 6, 2014
Results First Submitted: July 13, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: July 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