A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Care2Sleep
- Sleep Education
Treatment groups
672 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, Los Angeles
Lead sponsor
University of California, San Diego
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
Source ClinicalTrials.gov