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Идёт набор NCT05452031

A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Без фазы С лечением Sleep

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: Care2Sleep, Sleep Education.
Кому может быть актуально
Состояния в реестре: Sleep. Базовые параметры: от 18 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
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Официальное название

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Обзор

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.

Вмешательства

  • Поведенческое Care2Sleep
    A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
  • Поведенческое Sleep Education
    This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Первичные конечные точки

  • Sleep efficiency-Actigraphy [Срок оценки: Change from Baseline Sleep Efficiency at 6 months]
  • Pittsburgh Sleep Quality Index score [Срок оценки: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months]
Вторичные конечные точки (6)
  • Total score of Revised Memory and Behavior Problem Checklist [Срок оценки: Immediately AND 6 months after the last session of the intervention]
  • Total score of Quality of Life-Alzheimer's Disease Scale [Срок оценки: Immediately AND 6 months after the last session of the intervention]
  • Total score of Zarit Burden Interview [Срок оценки: Immediately AND 6 months after the last session of the intervention]
  • Total score of Center for Epidemiological Study of Depression Scale [Срок оценки: Immediately AND 6 months after the last session of the intervention]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) global health score [Срок оценки: Immediately AND 6 months after the last session of the intervention]
  • Levels of inflammatory markers [Срок оценки: Immediately AND 6 months after the last session of the intervention]

Критерии участия

Inclusion Criteria for Patients

  • Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
  • Community-dwelling
  • >1 sleep problems >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged >60 years
  • Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
  • Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
  • Have no severe medical conditions with a life expectancy of less than 6 months
  • Have an eligible caregiver

Inclusion Criteria for Caregivers

  • Live with an eligible patient
  • Aged >18 years
  • Is related to the patient as a family member, a significant other, or a friend
  • Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
  • Pittsburgh Sleep Quality Index (PSQI) total score >5
  • Montreal Cognitive Assessment (MoCA) ≥23
  • Can communicate in English

Критерии исключения

  • Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
  • Paid, professional caregivers will also be excluded.
  • If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 3 центра
  • University of California San Diego — La Jolla
  • University of California Los Angeles — Los Angeles
  • Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles

Идентификаторы

NCT: NCT05452031 · 1R01AG076756-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗