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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR016461-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.
This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F1U1 | Experimental | Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability. |
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| F1U2 | Experimental | Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability |
|
| F2U2 | Experimental | Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability |
|
| F2U3 | Experimental | Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability |
|
| F2U4 | Experimental | Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Using Mentored Behavioral and Environmental Restructuring | Behavioral | SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Baseline |
| Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Post-Treatment (Month 6 Post-Baseline) |
| Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Month 9 Post-Baseline |
| Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Baseline |
| Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Post-Treatment (Month 6 Post-Baseline) |
| Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Month 9 Post-Baseline |
| Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Chodosh, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36716989 | Derived | Chodosh J, Mitchell MN, Cadogan M, Brody AA, Alessi CA, Hernandez DE, Mangold M, Martin JL. Improving sleep using mentored behavioral and environmental restructuring (SLUMBER): A randomized stepped-wedge design trial to evaluate a comprehensive sleep intervention in skilled nursing facilities. Contemp Clin Trials. 2023 Mar;126:107107. doi: 10.1016/j.cct.2023.107107. Epub 2023 Jan 27. |
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This is a stepped wedge intervention trial (SWT). In this SWT, all units receive the intervention but at different time points. Every unit provides baseline and follow-up data.
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| ID | Title | Description |
|---|---|---|
| FG000 | F1U1 | Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability. |
| FG001 | F1U2 | Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability |
| FG002 | F2U2 | Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability |
| FG003 | F2U3 | Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability |
| FG004 | F2U4 | Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability |
| FG005 | F3U1 | Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Month 0-Month 3) |
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| Intervention (Month 3-Month 6) |
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| Sustainability Follow-Up 1 (Month 6-9) |
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| Sustainability Follow-Up 2 (Month 9-12) |
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| ID | Title | Description |
|---|---|---|
| BG000 | F1U1 | Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability |
| BG001 | F1U2 | Sequence 2: (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability |
| 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 | Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of time in bed | Baseline |
|
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 | Resident of the Skilled Nursing Facility | Sleep Using Mentored Behavioral and Environmental Restructuring: SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Chodosh, MD, MSHS | NYU Langone Health | (212) 263-6768 | Joshua.Chodosh@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2018 | Apr 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| F3U1 | Experimental | Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability |
|
|
|
| Baseline |
| Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. | Post-Treatment (Month 6 Post-Baseline) |
| Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. | Month 9 Post-Baseline |
| Score on Pittsburgh Sleep Quality Index (PSQI) | PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas. | Month 9 Post-Baseline |
| Brief Anxiety and Depression Scale (BADS) Questionnaire Score | BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment | Month 9 Post-Baseline |
| Score on Brief Cognitive Assessment Tool (BCAT) | BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living. | Month 9 Post-Baseline |
| Refused |
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| Withdrawal by Subject |
|
| Death |
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| COVID-Incomplete (couldn't collect all subject data due to Nursing Home COVID shutdown) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | F2U2 | Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability |
| BG003 | F2U3 | Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability |
| BG004 | F2U4 | Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability |
| BG005 | F3U1 | Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of time in bed | Post-Treatment (Month 6 Post-Baseline) |
|
|
|
| Primary | Sleep Efficiency (SE) | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of time in bed | Month 9 Post-Baseline |
|
|
|
| Primary | Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | Minutes | Baseline |
|
|
|
| Primary | Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Posted | Mean | 95% Confidence Interval | Minutes | Post-Treatment (Month 6 Post-Baseline) |
|
|
|
| Primary | Nighttime Total Awake Time | Data will be obtained from antigraphy analysis. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | Minutes | Month 9 Post-Baseline |
|
|
|
| Primary | Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | Minutes | Baseline |
|
|
|
| Primary | Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | Minutes | Post-Treatment (Month 6 Post-Baseline) |
|
|
|
| Primary | Daytime Sleeping (Napping) Time | Wrist device / actigraphy will be used to measure sleep/wake time. | Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure. | Posted | Mean | 95% Confidence Interval | Minutes | Month 9 Post-Baseline |
|
|
|
| Primary | Score on Pittsburgh Sleep Quality Index (PSQI) | PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas. | Posted | Mean | Full Range | score on a scale | Month 9 Post-Baseline |
|
|
|
| Primary | Brief Anxiety and Depression Scale (BADS) Questionnaire Score | BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment | Posted | Mean | Full Range | score on a scale | Month 9 Post-Baseline |
|
|
|
| Primary | Score on Brief Cognitive Assessment Tool (BCAT) | BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living. | Posted | Mean | Full Range | score on a scale | Month 9 Post-Baseline |
|
|
|
| 9 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
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| D001523 |
| Mental Disorders |