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Recruiting NCT05820919

Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase

No phase Interventional Alzheimer Disease Dementia Sleep Disorder Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LOCK Sleep Program, No intervention (control period/baseline data collection).
Who it may be relevant to
Registry conditions: Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral LOCK Sleep Program
    The LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices).
  • Other No intervention (control period/baseline data collection)
    Each NH serves as its own control. During the control period, baseline data will be collected.

Primary outcome measures

  • Sleep (actigraph measurement) [Time frame: 15 week sleep intervention period]
Secondary outcome measures (5)
  • Psychotropic medication use [Time frame: 15 week sleep intervention period]
  • Pain treatment received [Time frame: 15 week sleep intervention period]
  • Pain - Resident Report [Time frame: 15 week sleep intervention period]
  • Pain - Staff Report [Time frame: 15 week sleep intervention period]
  • Activities of daily living decline [Time frame: 15 week sleep intervention period]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Vivage/Beecan Corporation — Lakewood
  • National HealthCare Corporation — Murfreesboro
  • Caraday Healthcare, LLC — San Marcos

Identifiers

NCT: NCT05820919 · R33AG065619

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗