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Идёт набор NCT06549452

Mobile Health Intervention to Improve Exercise in Pediatric PH

Без фазы С лечением Pulmonary Arterial Hypertension

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: mHealth Intervention, Usual Care.
Кому может быть актуально
Состояния в реестре: Pulmonary Arterial Hypertension. Базовые параметры: 10 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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Официальное название

MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH

Обзор

Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.

Вмешательства

  • Устройство mHealth Intervention
    Our HIPPA-compliant texting platform is linked to the Fitabase Interface. Real time activity data are transmitted from the participant's smartphone to Fitabase via cellular network. Participants will receive 3-5 texts/day in sync with their preferred schedule defined at enrollment and taking into account school schedules as relevant. These texts use personal, disease-specific, and provider information to deliver two types of messages customized to the current step count and sent in equal proport
  • Устройство Usual Care
    Routine medical care

Первичные конечные точки

  • Change in average daily step count from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
Вторичные конечные точки (12)
  • Change in Quality of Life as measured by the Short Form 36-Item Health Survey (SF-36) [Срок оценки: Baseline to 12 weeks]
  • Change in Quality of Life as measured by the emPHasis-10 [Срок оценки: Baseline to 12 weeks]
  • Change in Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: Baseline to 12 weeks]
  • Change in Quality of Life as measured by the Pediatric Inventory for Parents (PIP) [Срок оценки: Baseline to 12 weeks]
  • Difference in total daily activity from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in unadjusted raw daily steps from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in total daily aerobic time from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in frequency of goal attainment from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in mean daily steps during week 12 and week 18 [Срок оценки: Week 12 & Week 18]
  • Difference in B-type natriuretic peptide levels from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in 6-Minute walk test distance from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]
  • Difference in Echocardiographic pericardial effusion from baseline to 12 weeks [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

  • Adolescents between ages 10-21 years.
  • Diagnosed with WHO Group 1 PAH or WHO Group 4 PH (CTEPH)
  • WHO functional class I-III
  • Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.

Критерии исключения

  • Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
  • Pregnancy
  • Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
  • Functional class IV heart failure
  • Requirement of > 2 diuretic adjustment in the prior three months.
  • Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
  • Involved in any other investigational intervention.

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 · 1 центр
  • Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT06549452 · 240771 · 1R34HL173389

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗