Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER)

NYU Langone Health

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03327324

1R01NR016461-01A1 (U.S. NIH Grant/Contract)

17-00338

Details and patient eligibility

About

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.

Full description

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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 6 patient groups

F1U1

Experimental group

Description:

Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

F1U2

Experimental group

Description:

Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

F2U2

Experimental group

Description:

Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

F2U3

Experimental group

Description:

Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

F2U4

Experimental group

Description:

Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring

F3U1

Experimental group

Description:

Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability

Treatment:

Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring