Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorSeoul National University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
eDrugSafe
Other interventionThe 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Intervention group: eDrugSafeExperimental treatment 1 intervention
Group B: Control group: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 month2
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 monthSecondary outcomes
1
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 month2
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 month3
Effectiveness: Emergency room visits
* Units of Measure: Number of emergency room visits (count) * Description: Higher counts reflect poor health outcomes.
Time frame
6 month4
Effectiveness: Hospitalizations
* Units of Measure: Number of hospitalizations (count) * Description: Higher counts reflect poor health outcomes.
Time frame
6 monthOther outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University
Lead sponsor
Ministry of Food and Drug Safety, Korea
Collaborator
Source ClinicalTrials.gov