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

Seoul National University

Status: Enrolling

Conditions: Drug Labelling; Mobile Health; Medication Management

Treatments: Other: eDrugSafe

Study type: Interventional

Funder types: Other

Identifiers

NCT06703697

SNUH IRB 2403_002-015

22183MFDS499 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Intervention group: eDrugSafe

Experimental group

Description:

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.

Treatment:

Other: eDrugSafe

Control group: Usual care

No Intervention group

Description:

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