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

N/ARecruitingNCT05452031

University of California, Los Angeles672 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

672

Conditions

Sleep

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

University of California San Diego

La Jolla, California, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, United States

RECRUITING

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

RECRUITING

Outcomes

Primary Outcomes

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 months

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 months

Secondary Outcomes

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.