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Идёт набор NCT06290401

A Socio-ecological Approach for Improving Self-management in Adolescents With SCD

Без фазы С лечением Anemia, Sickle Cell

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: SCThrive, SCHealthED.
Кому может быть актуально
Состояния в реестре: Anemia, Sickle Cell. Базовые параметры: 13 лет — 21 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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Обзор

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics. The main question\[s\]it aims to answer are: * Does SCThrive improve patient activation? * Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits? * Are any improvements maintained 3 months after treatment? Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive). Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

Подробное описание

The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.

Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).

Вмешательства

  • Поведенческое SCThrive
    SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.
  • Другое SCHealthED
    Standard of care plus 7 SCD educational text messages to ensure education is uniform across sites

Первичные конечные точки

  • Patient Activation [Срок оценки: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
Вторичные конечные точки (5)
  • Self-Management Behaviors [Срок оценки: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
  • Daily Functioning [Срок оценки: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
  • Emergency Room (ER) Visits [Срок оценки: 6 months prior to treatment; 6 months post-treatment]
  • Self-Management Skills [Срок оценки: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]
  • Health-related quality of life [Срок оценки: baseline, up to 4 weeks after treatment ends, 3 to 4 months after treatment ends]

Критерии участия

Критерии включения

  • Patient of a participating SCD Clinic
  • Confirmed diagnosis of SCD
  • 13-21 years of age

Критерии исключения

  • Another chronic disease (which would complicate measurement of patient activation)
  • Non-English-speaking
  • Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Nemours Children's Health — Wilmington
  • Children's Healthcare of Atlanta — Atlanta
  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT06290401 · 2023-0671

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗