Clinical trial NCT05452031: A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
Official title: A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Keywords: Dementia
Caregivers
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: VA Greater Los Angeles Healthcare System
First posted: 2022-07-11
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Sleep efficiency-Actigraphy
timeFrame: Change from Baseline Sleep Efficiency at 6 months
measure: Pittsburgh Sleep Quality Index score
timeFrame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Secondary outcomes:
measure: Total score of Revised Memory and Behavior Problem Checklist
timeFrame: Immediately AND 6 months after the last session of the intervention
measure: Total score of Quality of Life-Alzheimer's Disease Scale
timeFrame: Immediately AND 6 months after the last session of the intervention
measure: Total score of Zarit Burden Interview
timeFrame: Immediately AND 6 months after the last session of the intervention
measure: Total score of Center for Epidemiological Study of Depression Scale
timeFrame: Immediately AND 6 months after the last session of the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
timeFrame: Immediately AND 6 months after the last session of the intervention
measure: Levels of inflammatory markers
timeFrame: Immediately AND 6 months after the last session of the intervention
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Veterans Affairs Greater Los Angeles Healthcare System
state: California
Study officials:
References: