Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eDrugSafe.
- Who it may be relevant to
- Registry conditions: Mobile Health, Medication Management, Drug Labelling. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Effectiveness: medication adherence [Time frame: baseline, 3 month, 6 month]
- Effectiveness: self-efficacy in medication management [Time frame: baseline, 3 month, 6 month]
Secondary outcome measures (4)
- Effectiveness: Health-related quality of life [Time frame: 6 month]
- Effectiveness: Health-related quality of life [Time frame: 6 month]
- Effectiveness: Emergency room visits [Time frame: 6 month]
- Effectiveness: Hospitalizations [Time frame: 6 month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Seoul National University — Seoul
Identifiers
NCT: NCT06703697 · SNUH IRB 2403_002-015 · 22183MFDS499