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

Study Overview
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Brief Summary
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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.

Official Title
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A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: Care2Sleep
* Behavioral: Sleep Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Person Care2Sleep<br>In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy | Behavioral: Care2Sleep<br>* A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.<br>|
| Active Comparator: Telehealth Care2Sleep<br>Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy | Behavioral: Care2Sleep<br>* A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.<br>|
| Placebo Comparator: Sleep Education only<br>In-person, education on sleep, aging, and dementia but without specific or individualized recommendations | Behavioral: Sleep Education<br>* This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Change from Baseline Pittsburgh Sleep Quality Index score at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately AND 6 months after the last session of the intervention | 
| Total score of Quality of Life-Alzheimer's Disease Scale | Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia | Immediately AND 6 months after the last session of the intervention | 
| Total score of Zarit Burden Interview | Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers | Immediately AND 6 months after the last session of the intervention | 
| Total score of Center for Epidemiological Study of Depression Scale | Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers | Immediately AND 6 months after the last session of the intervention | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) global health score | Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers | Immediately AND 6 months after the last session of the intervention | 
| Levels of inflammatory markers | Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only | Immediately AND 6 months after the last session of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Caregivers