Clinical trial NCT06703697: Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)
Official title: Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2024-11-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness: medication adherence
timeFrame: baseline, 3 month, 6 month
measure: Effectiveness: self-efficacy in medication management
timeFrame: baseline, 3 month, 6 month
Secondary outcomes:
measure: Effectiveness: Health-related quality of life
timeFrame: 6 month
measure: Effectiveness: Health-related quality of life
timeFrame: 6 month
measure: Effectiveness: Emergency room visits
timeFrame: 6 month
measure: Effectiveness: Hospitalizations
timeFrame: 6 month
Other outcomes:
measure: Implementation: Feasibility of mobile web platform
timeFrame: 6-month follow-up (intervention group only)
measure: Implementation: Usability of mobile web platform
timeFrame: 6-month follow-up (intervention group only)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
state: Gwanak-gu
Study officials:
References: