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

NCT06703697 | Recruiting

• 2 other identifiers: SNUH IRB 2403_002-01522183MFDS499
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobile Health; Medication Management; Drug Labelling

Keywords

Mobile Health; Medication Management; Drug E-label; electronic labeling; hybrid study; implementation; cluster randomized trial; Electronic Medicinal Product Information (ePI)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, 3 month, 6 month

Secondary Outcomes (4)

• Effectiveness: Health-related quality of life

  6 month

• Effectiveness: Health-related quality of life

  6 month

• Effectiveness: Emergency room visits

  6 month

• Effectiveness: Hospitalizations

  6 month

Other Outcomes (2)

• Implementation: Feasibility of mobile web platform

  6-month follow-up (intervention group only)

• Implementation: Usability of mobile web platform

  6-month follow-up (intervention group only)

Study Arms (2)

Intervention group: eDrugSafe

EXPERIMENTAL

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

Control group: Usual care

NO INTERVENTION

Participants will use traditional methods, like paper, for managing and accessing medication information. Use of any digital platforms is not permitted in this group.

Interventions

eDrugSafe OTHER

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

Intervention group: eDrugSafe

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Individuals who have provided direct consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University

Seoul, Gwanak-gu, 08826, South Korea

RECRUITING

Central Study Contacts

Jung-Mi Oh, Pharm.D

CONTACT

+82 10 4880 5699; jmoh@snu.ac.kr

Da Eun Lee, Master, Pharm.D

CONTACT

+82 10 9251 9491; lde090168@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 25, 2024
• Study Start: August 12, 2024
• Primary Completion: December 15, 2024
• Study Completion: July 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)