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

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

ArmDescriptionAssigned Intervention
Experimental
In-Person Care2Sleep
In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
  • Behavioral: Care2Sleep
    A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Active Comparator
Telehealth Care2Sleep
Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
  • Behavioral: Care2Sleep
    A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Placebo Comparator
Sleep Education only
In-person, education on sleep, aging, and dementia but without specific or individualized recommendations
  • Behavioral: Sleep Education
    This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Recruiting Locations

University of California San Diego
La Jolla 5363943, California 5332921 92093
Contact:
Brent Mausbach, PhD
858-822-7529
bmausbach@health.ucsd.edu

University of California Los Angeles
Los Angeles 5368361, California 5332921 90095
Contact:
Yeonsu Song, PhD

Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles 5368361, California 5332921 91343
Contact:
Yeonsu Song, PhD
818-891-7711

More Details

Status
Recruiting
Sponsor
University of California, Los Angeles

Study Contact

Yeonsu Song
310-983-3029
ysong@sonnet.ucla.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.