Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

Detailed Description

This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• living in the unit of intervention,
• 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 show enthusiasm for the research
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: F1U1; Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.	Behavioral: 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 Names: SLUMBER
EXPERIMENTAL: F1U2; Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability	Behavioral: 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 Names: SLUMBER
EXPERIMENTAL: F2U2; Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability	Behavioral: 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 Names: SLUMBER
EXPERIMENTAL: F2U3; Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability	Behavioral: 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 Names: SLUMBER
EXPERIMENTAL: F2U4; Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability	Behavioral: 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 Names: SLUMBER
EXPERIMENTAL: F3U1; Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability	Behavioral: 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 Names: SLUMBER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2018
• Primary Completion (ACTUAL): February 23, 2021
• Study Completion (ACTUAL): February 23, 2021

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-00338; 1R01NR016461-01A1 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No