Меню
Идёт набор NCT05820919

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

Без фазы С лечением Alzheimer Disease Dementia Sleep Disorder Sleep Disturbance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: LOCK Sleep Program, No intervention (control period/baseline data collection).
Кому может быть актуально
Состояния в реестре: Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance. Базовые параметры: от 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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).
  • Другое No intervention (control period/baseline data collection)
    Each NH serves as its own control. During the control period, baseline data will be collected.

Первичные конечные точки

  • Sleep (actigraph measurement) [Срок оценки: 15 week sleep intervention period]
Вторичные конечные точки (5)
  • Psychotropic medication use [Срок оценки: 15 week sleep intervention period]
  • Pain treatment received [Срок оценки: 15 week sleep intervention period]
  • Pain - Resident Report [Срок оценки: 15 week sleep intervention period]
  • Pain - Staff Report [Срок оценки: 15 week sleep intervention period]
  • Activities of daily living decline [Срок оценки: 15 week sleep intervention period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Vivage/Beecan Corporation — Lakewood
  • National HealthCare Corporation — Murfreesboro
  • Caraday Healthcare, LLC — San Marcos

Идентификаторы

NCT: NCT05820919 · R33AG065619

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗