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Идёт набор NCT05383911

Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)

Без фазы С лечением Sickle Cell Disease

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: SCD Shared Decision-Making Toolkit for AYAs - including VR, SCD Shared Decision-Making Toolkit for AYAs - without VR.
Кому может быть актуально
Состояния в реестре: Sickle Cell Disease. Базовые параметры: от 15 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 →

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Обзор

This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.

Вмешательства

  • Поведенческое SCD Shared Decision-Making Toolkit for AYAs - including VR
    The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including virtual reality, online (videos, animations, articles), and print materials); and 3) implementation (e.g., clinic audit and feedback strategies
  • Поведенческое SCD Shared Decision-Making Toolkit for AYAs - without VR
    The SCD Shared Decision-Making Toolkit for AYAs (SDMT-AYA) targets multi-level barriers to uptake of disease-modifying therapies by providing technology-enhanced tools for: 1) clinicians (i.e., training in motivational interviewing, values elicitation, and cultural humility); 2) AYAs and caregivers (i.e., user-centered multimedia decision aids, including online videos, animations, and articles as well as print materials); and 3) implementation (e.g., clinic audit and feedback strategies).

Первичные конечные точки

  • Acceptability of Intervention Measure (AIM) [Срок оценки: Within 2 weeks post-intervention]
  • Patient/Caregiver Satisfaction Questionnaire [Срок оценки: Within 2 weeks post-intervention]
  • Feasibility of Intervention Measure (FIM) [Срок оценки: Within 2 weeks post-intervention]
  • Participant Recruitment Rate [Срок оценки: Time of enrollment through study completion, approximately 12 months]
  • Shared Decision Making Questionnaire (SDM-Q-9) [Срок оценки: Within 2 weeks post-intervention]
  • Disease-Modifying Therapy Knowledge Questionnaire [Срок оценки: Within 2 weeks post-intervention]
Вторичные конечные точки (1)
  • Initiation of disease-modifying therapy [Срок оценки: Within 6 months post-intervention]

Критерии участия

Критерии включения

  • Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider.
  • Nemours SCD healthcare providers will also be included.
  • English language fluency is a requirement for all participants.

Критерии исключения

  • Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
  • Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients < 18 years).
  • Providers still completing training will be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Nemours Children's Hospital, Delaware — Wilmington

Идентификаторы

NCT: NCT05383911 · 348507

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗