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Набор по приглашению NCT06972979

Investigation of a Patient Support Intervention for Statin Medication Adherence

Без фазы С лечением Medication Adherence

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: Text Message Gamification and Remote Support.
Кому может быть актуально
Состояния в реестре: Medication Adherence. Базовые параметры: от 18 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 →
Официальное название

A Randomized Trial of Gamification and Remote Support to Improve Statin Adherence

Обзор

Statins have been demonstrated to significantly reduce the risk of cardiovascular disease, but adherence to these medications is suboptimal. Improving adherence can be challenging because it is multifactorial and behaviors often occur within the everyday lives of patients and are less addressable during a visit with a clinician. In this study, the investigators will conduct a randomized trial to evaluate a behaviorally-designed gamification intervention with remote nursing support to improve statin adherence.

Подробное описание

Improving medication adherence can be challenging because behaviors occur within the everyday lives of patients. Therefore, intermittent visit-based adherence interventions or refill reminders have had limited impact. Remote Patient Monitoring (RPM) has been demonstrated in other settings to improve daily health behaviors when combined with automated outreach and a behavioral change strategy, such as gamification. These approaches have been demonstrated to be effective for other daily behaviors such as increasing physical activity levels among a wide range of patient populations including those at elevated risk for major cardiovascular events. MedTrack is a text message-based remote patient monitoring program with several key components: (I) medication check-ins with the ability to set the time(s) for daily medication reminders, (II) a gamification experience to drive behavior change, (III) ability to identify a support partner who receives weekly updates on the patient's game status; (IV) access to an RN team for clinical questions and care coordination, and (V) patients' providers can see real-time progress within an electronic health record (EHR) integrated application.

Вмешательства

  • Поведенческое Text Message Gamification and Remote Support
    Participants in the intervention arm consists of several components: (I) medication check-ins with the ability to set the time(s) for daily medication reminders, (II) a gamification experience to drive behavior change, (III) ability to identify a support partner who receives weekly updates on the patient's game status; (IV) access to an RN team for clinical questions and care coordination, and (V) patients' providers can see real-time progress within an electronic health record (EHR) integrated

Первичные конечные точки

  • Statin adherence, population average [Срок оценки: 6-months after enrollment]
Вторичные конечные точки (1)
  • Statin adherence, proportion of population with PDC>=80% [Срок оценки: 6-months after enrollment]

Критерии участия

Критерии включения

  • Adults, age 18 and older
  • Have a phone or email on file to receive outreach to participate in the study
  • Have a primary care provider (PCP) employed by Ascension.
  • Prescribed a statin medication and had filled two statin prescriptions in the previous 12 months (one in the prior 6 months and another in the previous 6 to 12 months)
  • PDC <80% in the prior 12 months
  • Have consented for electronic communications with Ascension

Критерии исключения

  • Patients will be excluded if they do not meet our inclusion criteria.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Ascension Health — St Louis

Идентификаторы

NCT: NCT06972979 · RAS20250009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗