N/A
N=96
Improving Sleep in Veterans and Their CGs
Sleep Quality
Bottom Line
View on ClinicalTrials.gov: NCT02057068 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Subjective Sleep Quality — 8.41; 8.31; 5.98; 8.63 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SLEEP-E Dyads Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Sleep Quality |
8.41; 8.31; 5.98; 8.63 | <.001 sig |
| SECONDARY Mean Sleep Efficiency |
82.19; 82.55; 81.64; 82.09 | >.05 |
| SECONDARY BEF-SHI Total Number of Negative Sleep Hygiene Behaviors |
5.27; 4.39; 3.12; 4.51 | <.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02057068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.