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Recruiting NCT05452031

A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Trial Parameters

Condition Sleep
Sponsor University of California, Los Angeles
Study Type INTERVENTIONAL
Phase N/A
Enrollment 672
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-11-09
Completion 2027-05-31
Interventions
Care2SleepSleep Education

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.

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, sho

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