An interventional study of eDrugSafe in Mobile Health, Medication Management and Drug Labelling, sponsored by Seoul National University. Recruiting at 1 site in South Korea. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Seoul National University · Not applicable, Interventional, and Other
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:
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:
Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants will use the eDrugSafe mobile web platform to manage their medication history and access electronic medicinal product information (ePI). QR codes are provided with each prescription to connect users directly to ePI content.
Other: eDrugSafe
Participants will use traditional methods, like paper, for managing and accessing medication information. Use of any digital platforms is not permitted in this group.
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.
Also known as: eDrugSafe: mobile web platform
Effectiveness: 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
Implementation: Feasibility of mobile web platform
* 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.
Time frame: 6-month follow-up (intervention group only)
Implementation: Usability of mobile web platform
* 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.
Time frame: 6-month follow-up (intervention group only)
Plan to share: No — The decision not to share individual participant data is based on the potential inclusion of certain personal information in the research data. Furthermore, informed consent was not obtained from participants for the disclosure of their information to third parties or public databases.
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2024, 4 months after the start.
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Seoul National University