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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| VA Greater Los Angeles Healthcare System | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Care2Sleep | Experimental | In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
|
| Telehealth Care2Sleep | Active Comparator | Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy |
|
| Sleep Education only | Placebo Comparator | In-person, education on sleep, aging, and dementia but without specific or individualized recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care2Sleep | Behavioral | A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure. |
| 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 |
| 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 |
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Inclusion Criteria for Patients
Inclusion Criteria for Caregivers
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeonsu Song | Contact | 310-983-3029 | ysong@sonnet.ucla.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92093 | United States |
Materials generated under the project will be disseminated in accordance with policies at UCLA and NIH. Data products from this study will be made available without cost to researchers, students, and analysts. The final database (both GAD and LAD) will be managed at the UCLA School of Nursing Research Office Design & Data Core. User registration will be required through the Design & Data Core in order to access or download files.
Research data that documents, supports, and validates research findings and referenced resource from a publication will be made available by on-line publication date unless NIH policy specifies an earlier date.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Sleep Education | Behavioral | This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations |
|
| 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 |
| University of California Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Veterans Affairs Greater Los Angeles Healthcare System | Recruiting | Los Angeles | California | 91343 | United States |
|
| D001523 | Mental Disorders |