Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
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 Messaging Intervention Group.
- Кому может быть актуально
- Состояния в реестре: Transplant;Failure,Kidney, Transplant; Failure, Liver, Adherence, Medication, Adherence, Patient. Базовые параметры: 13 лет — 25 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients: A Micro-Randomized Trial
Обзор
Can the investigators create an effective way to improve adherence to immunosuppressant medication and reduce rejection, graft loss, and death in adolescents and young adults who have undergone kidney or liver transplantation? The investigators' mobile technology intervention uses real-time electronic pillbox-assessed dose timing and text message prompts to address antirejection medication nonadherence when nonadherence is detected.
Подробное описание
Over 1/3 of adolescents and young adults who have undergone kidney or liver transplantation are nonadherent to antirejection medicines, accounting for shockingly high rates of infections, rejection, graft loss, and even death. Recently, the American Society of Transplantation highlighted real-time adherence intervention as top priorities to address antirejection medication nonadherence, but these evidence-based intervention tools do not exist. The investigators aim to answer the American Society of Transplantation's call and fill these critical gaps in nonadherence management for adolescents and young adults with kidney or liver transplant. Specifically, electronic pillboxes yield valuable real-time daily dosing data to guide interventions for adolescents and young adult kidney or liver transplant recipients, but existing interventions have not optimally leveraged these devices' capabilities. Just-in-time adaptive interventions delivered via mobile device (i.e., Smartphone or tablet) are cutting-edge approaches that fully incorporate adolescents and young adults' daily dose behavior to automatically deliver tailored intervention content exactly when adolescents and young adults need it most. The investigators piloted a promising static medication adherence support text message intervention based on the COM-B model, a well-established behavioral health intervention model, which will be modified into a just-in-time adaptive intervention for adolescents and young adult kidney or liver transplant recipients. Given that 95% of adolescents and young adults in the USA own smartphones, the investigators hypothesize that the investigators' intervention will improve on-time dosing and reduce rejection, graft loss, and death. The investigators believe that providing adherence support text messages or praise text messages will result in a higher proportion of adolescents and young adults taking the next dose and maintaining improvements in adherence post-intervention. In summary, the investigators' just-in-time adaptive intervention leverages real-time electronic pillbox-assessed dosing behavior and Smartphone text messaging capabilities to address tacrolimus or sirolimus nonadherence when nonadherence is detected.
Вмешательства
- Поведенческое mHealth Messaging Intervention Group
Participants will receive an electronic pill box; the research team will instruct participants on how to use this device. Participants will be asked to use the electronic pill box for their prescribed medicines for the duration of the study (up to 16 months). During the 12-week micro-randomized trial, participants will be randomized within person to receive (1) adherence support text messages or (2) no text message after each missed dose, and (1) praise text message or (2) no text message after
Первичные конечные точки
- Electronically-measured medication adherence (dose taken or not) [Срок оценки: 16 months]
Вторичные конечные точки (1)
- Standard deviation of antirejection medication dose timing [Срок оценки: 16 months]
Критерии участия
Критерии включения
- Adolescents and young adults (13-25 years old) who underwent kidney or liver transplantation at least 6 months prior to enrollment
- Currently prescribed tacrolimus or sirolimus.
Критерии исключения
- Currently receiving dialysis
- Hospitalized for duration of study
- Significant developmental or cognitive delay
- No access to a mobile device that supports text messaging
- Decline to use electronic pill box to monitor daily medication adherence
- Non-English speaking
- If a participant meets inclusion criteria, enrolls in the study, and experiences graft failure potentially leading to dialysis in the case of kidney transplant recipients, the participant will be given the option to continue in the study if they remain on tacrolimus or sirolimus.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Johns Hopkins — Baltimore
Идентификаторы
NCT: NCT05613010 · IRB00321009 · K23DK128573