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Completed

NCT Number: NCT02057068

Improving Sleep in Veterans and Their CGs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLEEP-E Dyads Intervention

Behavioral

Described in arm/group description

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Emory University

Registry information

Official study title

Improving Sleep In Veterans and Their Family Caregivers

Acronym: SLEEP-E Dyads

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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