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This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.
This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonpharmacological sleep intervention | Experimental | The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. |
|
| Active control | Active Comparator | Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonpharmacological sleep intervention | Behavioral | The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index | The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality). | 3-month follow-up |
| Sleep Efficiency | Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed. | 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy A. Alessi, MD | VA Greater Los Angeles Healthcare System, Sepulveda, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Sepulveda, CA | Sepulveda | California | 91343 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22617164 | Result | Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1. | |
| 21450184 | Result | Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonpharmacological Sleep Intervention | The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. |
| FG001 | Active Control | Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonpharmacological Sleep Intervention | The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pittsburgh Sleep Quality Index | The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality). | Posted | Mean | Standard Deviation | units on a scale; 0-21 | 3-month follow-up |
|
This was a behavioral sleep education intervention. No medications or devices were tested. Data on adverse events were collected over the entire study period (12-months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonpharmacological Sleep Intervention | The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cathy Alessi | VA Greater Los Angeles Healthcare System | 818 895-9311 | cathy.alessi@va.gov |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Active control | Behavioral | Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). |
|
| 23834036 | Result | Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8. |
| Lost to Follow-up |
|
| BG001 | Active Control | Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Pittsburgh Sleep Quality Index | The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality). | Mean | Standard Deviation | units on a scale; 0-21 |
|
| Sleep efficiency | Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed. | Mean | Standard Deviation | Percentage of time asleep while in bed |
|
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| Primary | Sleep Efficiency | Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed. | Posted | Mean | Standard Deviation | percentage of time asleep while in bed | 3-month follow-up |
|
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| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | Active Control | Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). | 0 | 109 | 0 | 109 |
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| D001523 | Mental Disorders |