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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
360
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.
Seoul National University
Seoul, Gwanak-gu, South Korea
RECRUITINGEffectiveness: medication adherence
* Assessment: The Korean version of the Morisky Medication Adherence Scale-8 (MMAS-8) * Units of Measure: Total MMAS-8 score (range: 0-8) * Description: The MMAS-8 scale consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score \< 6 is considered low adherence, while a total score of ≥ 6 but \< 8 indicates moderate adherence, and a score of 8 indicates high adherence.
Time frame: baseline, 3 month, 6 month
Effectiveness: self-efficacy in medication management
* Assessment: The Korean version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) * Units of Measure: Total SEAMS score (range: 16-48) * Description: The SEAMS is a 16-item scale that assesses confidence in managing medications. Higher scores indicate greater self-efficacy and confidence in medication management.
Time frame: baseline, 3 month, 6 month
Effectiveness: Health-related quality of life
* Units of Measure: EQ-5D-5L Index (-1 to 1) * Description: Health-related quality of life at the 6-month follow-up will be assessed using the Korean EQ-5D-5L scale, administered electronically. The EQ-5D-5L measures five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels (no problems to extreme problems). Responses are converted to an index value (1: full health to 0: death; below 0: worse than death) using a validated Korean scoring algorithm.
Time frame: 6 month
Effectiveness: Health-related quality of life
* Units of Measure: EQ-5D-5L VAS Score (0 to 100) * Description: Health-related quality of life at the 6-month follow-up will be assessed using the Korean EQ-5D-5L scale, administered electronically. A Visual Analogue Scale (VAS) will also measure self-rated health on a scale from 0 (worst) to 100 (best), administered concurrently with the EQ-5D-5L.
Time frame: 6 month
Effectiveness: Emergency room visits
* Units of Measure: Number of emergency room visits (count) * Description: Higher counts reflect poor health outcomes.
Time frame: 6 month
Effectiveness: Hospitalizations
* Units of Measure: Number of hospitalizations (count) * Description: Higher counts reflect poor health outcomes.
Time frame: 6 month
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