A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Care2Sleep, Sleep Education.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
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.
Interventions
- Behavioral Care2Sleep
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure. - Behavioral Sleep Education
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Primary outcome measures
- Sleep efficiency-Actigraphy [Time frame: Change from Baseline Sleep Efficiency at 6 months]
- Pittsburgh Sleep Quality Index score [Time frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months]
Secondary outcome measures (6)
- Total score of Revised Memory and Behavior Problem Checklist [Time frame: Immediately AND 6 months after the last session of the intervention]
- Total score of Quality of Life-Alzheimer's Disease Scale [Time frame: Immediately AND 6 months after the last session of the intervention]
- Total score of Zarit Burden Interview [Time frame: Immediately AND 6 months after the last session of the intervention]
- Total score of Center for Epidemiological Study of Depression Scale [Time frame: Immediately AND 6 months after the last session of the intervention]
- Patient-Reported Outcomes Measurement Information System (PROMIS) global health score [Time frame: Immediately AND 6 months after the last session of the intervention]
- Levels of inflammatory markers [Time frame: Immediately AND 6 months after the last session of the intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- University of California San Diego — La Jolla
- University of California Los Angeles — Los Angeles
- Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles
Identifiers
NCT: NCT05452031 · 1R01AG076756-01