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NCT05452031 | RECRUITING | Sleep

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

University of California, Los Angeles

Information provided by (Responsible Party):

Yeonsu Song, PhD, RN, FNP

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.

Condition or disease

Sleep

Intervention/treatment

Care2Sleep

Sleep Education

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 672 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
Actual Study Start Date : 2022-11-09
Estimated Primary Completion Date : 2027-05-31
Estimated Study Completion Date : 2027-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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, 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.
    A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

    Location Details

    NCT05452031

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    How to Participate

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    Locations

    RECRUITING

    United States, California

    University of California San Diego

    THE JOLLA, California, United States, 92093

    RECRUITING

    United States, California

    University of California Los Angeles

    Los Angeles, California, United States, 90095

    RECRUITING

    United States, California

    Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California, United States, 91343