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Clinical Trials/NCT05820919
NCT05820919
Recruiting
Not Applicable

Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program

University of Alabama, Tuscaloosa3 sites in 1 country456 target enrollmentSeptember 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University of Alabama, Tuscaloosa
Enrollment
456
Locations
3
Primary Endpoint
Sleep (actigraph measurement)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2023
End Date
May 29, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Alabama, Tuscaloosa
Responsible Party
Principal Investigator
Principal Investigator

A. Lynn Snow

Professor

University of Alabama, Tuscaloosa

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

Outcomes

Primary Outcomes

Sleep (actigraph measurement)

Time Frame: 15 week sleep intervention period

Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)

Secondary Outcomes

  • Pain - Resident Report(15 week sleep intervention period)
  • Activities of daily living decline(15 week sleep intervention period)
  • Psychotropic medication use(15 week sleep intervention period)
  • Pain treatment received(15 week sleep intervention period)
  • Pain - Staff Report(15 week sleep intervention period)

Study Sites (3)

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