Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)
NCT ID: NCT06703697
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2024-08-12
2025-07-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention group: eDrugSafe
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.
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.
Control group: Usual care
Participants will use traditional methods, like paper, for managing and accessing medication information. Use of any digital platforms is not permitted in this group.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Individuals who do not consent to participate in the study or who withdraw their consent.
18 Years
79 Years
ALL
Yes
Sponsors
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Ministry of Food and Drug Safety, Korea
OTHER_GOV
Seoul National University
OTHER
Responsible Party
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Jung Mi Oh
Professor
Locations
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Seoul National University
Seoul, Gwanak-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Da Eun Lee, Master, Pharm.D
Role: backup
Jung-Mi Oh, Pharm.D
Role: backup
In-Wha Kim, Master, Ph.D
Role: backup
Ji Sun Chun, Pharm.D
Role: backup
Mari Kim, Pharm.D
Role: backup
Hyo Joo Jeon, Pharm.D
Role: backup
Seungyeon Lee, Pharm.D
Role: backup
Other Identifiers
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22183MFDS499
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SNUH IRB 2403_002-015
Identifier Type: -
Identifier Source: org_study_id