Status:
RECRUITING
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of California, San Diego
VA Greater Los Angeles Healthcare System
Conditions:
Sleep
Eligibility:
All Genders
18+ years
Phase:
NA
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 progr...
Eligibility Criteria
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.
Key Trial Info
Start Date :
November 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT05452031
Start Date
November 9 2022
End Date
August 31 2027
Last Update
March 26 2025
Active Locations (3)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343