Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase (40Winks)

University of Alabama, Tuscaloosa

Status: Enrolling

Conditions: Alzheimer Disease; Sleep Disorder; Sleep Disturbance; Dementia

Treatments: Other: No intervention (control period/baseline data collection); Behavioral: LOCK Sleep Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05820919

R33AG065619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 456 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Control (each NH acts as its own control):

Other group

Description:

Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin).

Treatment:

Other: No intervention (control period/baseline data collection)

Intervention (all NHs receive the intervention):

Experimental group

Description:

The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase.

Treatment:

Behavioral: LOCK Sleep Program