Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)

Официальное название

Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial

Обзор

The goal of this cluster randomized trial is to learn if eDrugSafe, a mobile web platform for drug electronic labeling (e-labeling) and medication management, can improve medication adherence and self-efficacy in adults who take multiple medications. This study will also assess whether eDrugSafe is feasible and acceptable for use in real clinical settings, especially in local pharmacies. The main questions it aims to answer are: * Can eDrugSafe improve medication adherence, self-efficacy, and quality of life for adults taking multiple medications and reduce hospitalizations? * Is eDrugSafe acceptable and feasible for implementing drug e-labeling and supporting medication management in community settings? Researchers will compare eDrugSafe to usual care (traditional paper methods) to see if eDrugSafe is effective in supporting adults who take multiple medications, and if it can be feasibly implemented in local pharmacies. Participants will: * Visit a local pharmacy randomly assigned to use eDrugSafe or traditional care methods and decide if they wish to join the study. * Use either eDrugSafe to access medication information and manage their medication history, or receive usual care with paper-based methods, for 6 months. * Complete surveys at the start of the study, at 3 months, and at 6 months to measure effectiveness and implementation outcomes.

Вмешательства

• Другое eDrugSafe
  The eDrugSafe mobile web platform enables management of medication history and provides electronic access to medicinal product information (ePI). QR codes are separately provided for prescription records to facilitate direct access to ePI.

Первичные конечные точки

• Effectiveness: medication adherence [Срок оценки: baseline, 3 month, 6 month]
• Effectiveness: self-efficacy in medication management [Срок оценки: baseline, 3 month, 6 month]

Вторичные конечные точки (4)

• Effectiveness: Health-related quality of life [Срок оценки: 6 month]
• Effectiveness: Health-related quality of life [Срок оценки: 6 month]
• Effectiveness: Emergency room visits [Срок оценки: 6 month]
• Effectiveness: Hospitalizations [Срок оценки: 6 month]

Критерии участия

Критерии включения

• Adults aged 18 to 79 years.
• Individuals who can speak and understand Korean.
• Possession of a personal electronic device capable of accessing mobile applications and web services over wireless internet (bring participants' own device, BYOD).
• Patients taking three or more medications with at least one medication prescribed for 28 days or longer.
• Individuals who have provided direct consent to participate in the study.

Критерии исключения

• Individuals using any mobile web platform other than eDrugSafe for medication safety information purposes after enrollment.
• Individuals who do not consent to participate in the study or who withdraw their consent.

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

Простое слепое

Основная цель

Другое

Центры проведения

South Korea · 1 центр

• Seoul National University — Seoul

Идентификаторы

NCT: NCT06703697 · SNUH IRB 2403_002-015 · 22183MFDS499

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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