RecruitingNot ApplicableNCT05452031

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

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers


Sponsor

University of California, Los Angeles

Enrollment

672 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria14

  • 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
  • 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 Criteria3

  • 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.

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Interventions

BEHAVIORALCare2Sleep

A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

BEHAVIORALSleep Education

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations


Locations(3)

University of California San Diego

La Jolla, California, United States

University of California Los Angeles

Los Angeles, California, United States

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

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NCT05452031


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