Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

Официальное название

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant

Обзор

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Подробное описание

Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Вмешательства

• Другое DOT intervention
  A mobile health application developed by eMocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence

Первичные конечные точки

• Medication adherence based on medication level variability index [Срок оценки: 12 weeks]
• Directly observed medication adherence [Срок оценки: 1 weeks]
• Late Acute Rejection [Срок оценки: 6 months post-intervention]
• Hospitalization [Срок оценки: 6 months post-intervention]
• Patient Activation Measure [Срок оценки: Pretest at enrollment and posttest at 12 weeks]
• Patient Assessment of Chronic Illness Care (PACIC) [Срок оценки: Pretest at enrollment and posttest at 12 weeks]
• Self-reported user satisfaction with the DOT app [Срок оценки: Pretest at enrollment and posttest at 12 weeks]
• Engagement metrics [Срок оценки: Pretest at enrollment and posttest at 12 weeks]
• PedsQL 3.0 Transplant Module (PedsQL-TM) [Срок оценки: Pretest at enrollment and posttest at 12 weeks]
• Adolescent Medication Barriers Scale (AMBS) [Срок оценки: Pretest, posttest]

Критерии участия

Критерии включения

• Eligible participants are 10-21 years of age
• Have received a heart transplant and are followed participating pediatric heart transplant centers
• English-speaking or Spanish-speaking
• Own a smart-phone or have access to the mobile app through other devices
• Are willing to receive information through it
• Have a MLVI score of greater than 2.0 over the last year

Критерии исключения

• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent

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

• University of Miami, Miller School of Medicine — Coral Gables
• University of Florida — Gainesville
• Joe DiMaggio Children's Hospital — Hollywood
• FSU College of Medicine — Tallahassee

Идентификаторы

NCT: NCT05732779 · IRB202201809 · R44HL167591-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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