Sleep
Conditions
Keywords
Dementia, Caregivers
Brief summary
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
Interventions
BEHAVIORALCare2Sleep
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
BEHAVIORALSleep Education
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Sponsors
University of California, Los Angeles
University of California, San Diego
VA Greater Los Angeles Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Patients * Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record * Community-dwelling * \>1 sleep problems \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged \>60 years * Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome) * Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound) * Have no severe medical conditions with a life expectancy of less than 6 months * Have an eligible caregiver Inclusion Criteria for Caregivers * Live with an eligible patient * Aged \>18 years * Is related to the patient as a family member, a significant other, or a friend * Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months * Pittsburgh Sleep Quality Index (PSQI) total score \>5 * Montreal Cognitive Assessment (MoCA) ≥23 * Can communicate in English
Exclusion criteria
* Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months. * Paid, professional caregivers will also be excluded. * If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency-Actigraphy | Change from Baseline Sleep Efficiency at 6 months | Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality |
| Pittsburgh Sleep Quality Index score | Change from Baseline Pittsburgh Sleep Quality Index score at 6 months | Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score of Revised Memory and Behavior Problem Checklist | Immediately AND 6 months after the last session of the intervention | Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors. |
| Total score of Quality of Life-Alzheimer's Disease Scale | Immediately AND 6 months after the last session of the intervention | Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia |
| Total score of Zarit Burden Interview | Immediately AND 6 months after the last session of the intervention | Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers |
| Total score of Center for Epidemiological Study of Depression Scale | Immediately AND 6 months after the last session of the intervention | Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers |
| Patient-Reported Outcomes Measurement Information System (PROMIS) global health score | Immediately AND 6 months after the last session of the intervention | Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers |
| Levels of inflammatory markers | Immediately AND 6 months after the last session of the intervention | Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only |
Countries
United States
Contacts
CONTACTYeonsu Song
Outcome results
None listed