Drug Labelling, Medication Management, Mobile Health
Conditions
Keywords
Mobile Health, Medication Management, Drug E-label, electronic labeling, hybrid study, implementation, cluster randomized trial, Electronic Medicinal Product Information (ePI)
Brief summary
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
OTHEReDrugSafe
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.
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 18 to 79 years. 2. Individuals who can speak and understand Korean. 3. Possession of a personal electronic device capable of accessing mobile applications and web services over wireless internet (bring participants' own device, BYOD). 4. Patients taking three or more medications with at least one medication prescribed for 28 days or longer. 5. Individuals who have provided direct consent to participate in the study.
Exclusion criteria
1. Individuals using any mobile web platform other than eDrugSafe for medication safety information purposes after enrollment. 2. Individuals who do not consent to participate in the study or who withdraw their consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: medication adherence | baseline, 3 month, 6 month | * 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. |
| Effectiveness: self-efficacy in medication management | baseline, 3 month, 6 month | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Hospitalizations | 6 month | * Units of Measure: Number of hospitalizations (count) * Description: Higher counts reflect poor health outcomes. |
| Effectiveness: Health-related quality of life | 6 month | * 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. |
| Effectiveness: Emergency room visits | 6 month | * Units of Measure: Number of emergency room visits (count) * Description: Higher counts reflect poor health outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation: Feasibility of mobile web platform | 6-month follow-up (intervention group only) | * Assessment: Semi-structured survey guided by the RE-AIM and CFIR frameworks * Units of Measure: Descriptive statistics of response frequencies (quantitative data) and qualitative analysis * Description: The survey assesses user perspectives across three areas: study background, experience with e-labels and the platform, and potential for adoption. Quantitative data will include descriptive statistics of response frequencies, while qualitative data will be analyzed using word coding to identify themes such as acceptability, adoption, feasibility, and barriers. |
| Implementation: Usability of mobile web platform | 6-month follow-up (intervention group only) | * Assessment: Korean System Usability Scale (SUS) * Units of Measure: SUS total score (range: 0-100) * Description: The SUS is a 10-item tool used to assess the usability of the mobile web platform. Scores range from 0 to 100 and are calculated by adjusting responses and multiplying the total by 2.5. A score above 68 is considered above average for usability. |
Countries
South Korea
Contacts
Primary ContactJung-Mi Oh, Pharm.D
Backup ContactDa Eun Lee, Master, Pharm.D
Outcome results
None listed