Improving sleep health for Alzheimer's patients and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to evaluate the effectiveness of the Care2Sleep intervention program on sleep quality, health status, and quality of life for both individuals with Alzheimer's disease and their caregivers. Participants will be randomly assigned to either in-person or telehealth versions of the Care2Sleep program or to an education control group. The intervention consists of five sessions, with assessments conducted immediately after the program and at a six-month follow-up to measure outcomes. The study spans five years and utilizes a behavioral intervention development model to guide its approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Yeonsu Song
• Email: ysong@sonnet.ucla.edu
• Phone: 310-983-3029

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.