Improving Sleep Using Mentored Behavioral and Environmental Restructuring
NCT ID: NCT03327324
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2018-03-27
2021-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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F1U1
Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
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.
F1U2
Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
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.
F2U2
Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
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.
F2U3
Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
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.
F2U4
Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
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.
F3U1
Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ability to communicate and follow simple commands,
* English- or Spanish-speaking,
* capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
Exclusion Criteria
* Does not have capacity and does not have a proxy.
* obtunded or comatose state,
* inability to communicate verbally,
* inability to consent and without surrogate
* non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Nursing Research (NINR)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Joshua Chodosh, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-00338
Identifier Type: -
Identifier Source: org_study_id
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