Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)

Not Applicable

Recruiting

• Conditions: Mobile Health; Medication Management; Drug Labelling

• Registration Number: NCT06703697
• Lead Sponsor: Seoul National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-12
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2024-12-15
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Effectiveness: Emergency room visits	6 month	* Units of Measure: Number of emergency room visits (count); * Description: Higher counts reflect poor health outcomes.
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 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.

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Gwanak-gu, Korea, Republic of