Clinical trial NCT03327324: Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Official title: Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2017-10-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Efficiency (SE)
timeFrame: Baseline
measure: Sleep Efficiency (SE)
timeFrame: Post-Treatment (Month 6 Post-Baseline)
measure: Sleep Efficiency (SE)
timeFrame: Month 9 Post-Baseline
measure: Nighttime Total Awake Time
timeFrame: Baseline
measure: Nighttime Total Awake Time
timeFrame: Post-Treatment (Month 6 Post-Baseline)
measure: Nighttime Total Awake Time
timeFrame: Month 9 Post-Baseline
measure: Daytime Sleeping (Napping) Time
timeFrame: Baseline
measure: Daytime Sleeping (Napping) Time
timeFrame: Post-Treatment (Month 6 Post-Baseline)
measure: Daytime Sleeping (Napping) Time
timeFrame: Month 9 Post-Baseline
measure: Score on Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Month 9 Post-Baseline
measure: Brief Anxiety and Depression Scale (BADS) Questionnaire Score
timeFrame: Month 9 Post-Baseline
measure: Score on Brief Cognitive Assessment Tool (BCAT)
timeFrame: Month 9 Post-Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh, MD
role: PRINCIPAL_INVESTIGATOR
References: