A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
Purpose
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.
Condition
- Sleep
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental In-Person Care2Sleep |
In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
|
|
Active Comparator Telehealth Care2Sleep |
Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
|
|
Placebo Comparator Sleep Education only |
In-person, education on sleep, aging, and dementia but without specific or individualized recommendations |
|
Recruiting Locations
La Jolla 5363943, California 5332921 92093
Los Angeles 5368361, California 5332921 90095
Yeonsu Song, PhD
Los Angeles 5368361, California 5332921 91343
Yeonsu Song, PhD
818-891-7711
More Details
- Status
- Recruiting
- Sponsor
- University of California, Los Angeles