Clinical trial NCT05820919: Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
Official title: Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Sleep Disorder
Sleep Disturbance
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Lowell
name: The University of Texas Health Science Center, Houston
name: University of Texas at Austin
name: Brown University
First posted: 2023-04-20
Enrollment: 456
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a wedge- based cluster randomized, controlled trial (RCT) design with each NH acting as its own control. The unit of random assignment is the NH. There are 24 NHs - 8 from each of 3 corporations. Each NH serves as its own control. Control data are collected for 1 week, then the intervention will begin with intervention data collected for 15 weeks (10-week active intervention period, and five-week sustainment period). All NHs are assigned to the control group and then phased into the intervention group at 37-week intervals (steps). Our stepped wedge design has 4 steps with 6 NHs per step (2 NHs per corporation per step). We will randomly assign the order in which the 8 NHs within each corporation are phased into the intervention group. We will randomize NHs within corporations to steps after matching on bed size and number of long-stay residents with ADRD diagnoses.
Primary purpose: TREATMENT

Brief summary: This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

Detailed description: Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency.

This is an incomplete stepped-wedge randomized controlled trial to test the impact and sustainability of the LOCK sleep program. In 24 community nursing homes (NHs)-eight from each of 3 national NH corporations-our multi-disciplinary team will examine these aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.

Eligibility criteria: Inclusion Criteria:

* Nursing home residents aged \>=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems

Exclusion Criteria:

* Residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
* Residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies

Primary outcomes:
measure: Sleep (actigraph measurement)
timeFrame: 15 week sleep intervention period
Secondary outcomes:
measure: Psychotropic medication use
timeFrame: 15 week sleep intervention period
measure: Pain treatment received
timeFrame: 15 week sleep intervention period
measure: Pain - Resident Report
timeFrame: 15 week sleep intervention period
measure: Pain - Staff Report
timeFrame: 15 week sleep intervention period
measure: Activities of daily living decline
timeFrame: 15 week sleep intervention period
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Vivage/Beecan Corporation
state: Colorado
city: Murfreesboro
country: United States
facility: National HealthCare Corporation
state: Tennessee
city: San Marcos
country: United States
facility: Caraday Healthcare, LLC
state: Texas
Study officials:
affiliation: The University of Alabama
name: Lynn Snow, PhD
role: PRINCIPAL_INVESTIGATOR
References: