跳至主要内容
临床试验/NCT05820919
NCT05820919招募中不适用

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

University of Alabama, Tuscaloosa6 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2023年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
456
试验地点
6
主要终点
Sleep (actigraph measurement)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Sleep (actigraph measurement)

时间窗: 15 week sleep intervention period

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

次要结局

  • 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)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Lynn Snow

Professor

University of Alabama, Tuscaloosa

研究点 (6)

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