Improving Sleep Using Mentored Behavioral and Environmental Restructuring

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

• Registration Number: NCT03327324
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Study Start: 2018-03-27
• Primary Completion: 2021-02-23
• Study Completion: 2021-02-23
• Results First Submitted: 2022-06-16
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
F1U1	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
F2U3	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
F2U4	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
F1U2	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
F3U1	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
F2U2	Sleep Using Mentored Behavioral and Environmental Restructuring	Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability

Primary Outcome Measures

Name	Time	Method
Daytime Sleeping (Napping) Time	Month 9 Post-Baseline	Wrist device / actigraphy will be used to measure sleep/wake time.
Score on Pittsburgh Sleep Quality Index (PSQI)	Month 9 Post-Baseline	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.
Nighttime Total Awake Time	Month 9 Post-Baseline	Data will be obtained from antigraphy analysis.
Brief Anxiety and Depression Scale (BADS) Questionnaire Score	Month 9 Post-Baseline	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
Score on Brief Cognitive Assessment Tool (BCAT)	Month 9 Post-Baseline	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.
Sleep Efficiency (SE)	Month 9 Post-Baseline	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States