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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Care2Sleep
BehavioralA multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Sleep Education
BehavioralThis group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Treatment groups
672 Participants
are divided into 3 treatment groupsGroup A: In-Person Care2SleepExperimental treatment 1 intervention
Group B: Telehealth Care2SleepActive comparator 1 intervention
Group C: Sleep Education onlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep efficiency-Actigraphy
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
Time frame
Change from Baseline Sleep Efficiency at 6 months2
Pittsburgh Sleep Quality Index score
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.
Time frame
Change from Baseline Pittsburgh Sleep Quality Index score at 6 monthsSecondary outcomes
1
Total score of Revised Memory and Behavior Problem Checklist
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.
Time frame
Immediately AND 6 months after the last session of the intervention2
Total score of Quality of Life-Alzheimer's Disease Scale
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
Time frame
Immediately AND 6 months after the last session of the intervention3
Total score of Zarit Burden Interview
Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers
Time frame
Immediately AND 6 months after the last session of the intervention4
Total score of Center for Epidemiological Study of Depression Scale
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
Time frame
Immediately AND 6 months after the last session of the interventionSponsors and contacts
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University of California, Los Angeles
Lead sponsor
University of California, San Diego
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
Source ClinicalTrials.gov