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Набор скоро начнётся NCT05618444

Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Без фазы С лечением Obstructive Sleep Apnea

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: Automated Management (AM).
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea. 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

Enhancing Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)

Обзор

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

Подробное описание

This feasibility study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and effectiveness of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with obstructive sleep apnea (OSA) (N=50). A prospective, randomized, parallel group, unblinded, feasibility trial is proposed. AM is a tele-management strategy that includes evidence-based components for improving shorter-term PAP adherence consisting of education, support and troubleshooting, and brief targeted motivational enhancement delivered by tele-messaging. The automated, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based intervention is designed to ensure access to sustained care that overcomes barriers such as distance/geography, transportation limitations or lost work/productivity time. As such, AM can provide equitable access to quality PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for PAP adherence, these strategies may alter OSA care paradigms, improve outcomes and associated healthcare costs, and reduce disparities.

Вмешательства

  • Поведенческое Automated Management (AM)
    A tele-management intervention that will deliver text messages to participants via a bot - a computer program that simulates human outreach activity. Programmed messages will address evidence based intervention components for positive airway pressure (PAP) adherence, including PAP use awareness (tele-monitoring), support and troubleshooting, education, and brief motivational messaging.

Первичные конечные точки

  • Patient Satisfaction [Срок оценки: 6 months]
  • Acceptability [Срок оценки: 6 months]
  • Appropriateness [Срок оценки: 6 months]
Вторичные конечные точки (2)
  • Recruitment Rate [Срок оценки: 6 months]
  • Retention Rate [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Spanish-speaking and reading
  • Self-identified Hispanic
  • Adults ≥ 18 years-old
  • Males and females
  • Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%)
  • Expected availability for the duration of the study (6 months from date of randomization)
  • Ownership of smartphone with unlimited text messaging capability
  • Referred to PAP treatment and able and willing to be treated with PAP

Критерии исключения

  • Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT)
  • Requirement of supplemental oxygen or other non-invasive ventilation modality
  • Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded)
  • Anticipated or scheduled bariatric surgery and/or referred to sleep evaluation by bariatric surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Kaiser Permanent Southern California — Fontana
  • University of Kansas Medical Center — Kansas City
  • Geisinger — Danville
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT05618444 · 2022-0810 · 375-SR-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗