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

NCT06703697 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-11-27

No results posted yet for this study

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

Interventions

OTHER

eDrugSafe

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 & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Seoul National University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2024-12-15
Completion
2025-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703697 on ClinicalTrials.gov