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| ID | Type | Description | Link |
|---|---|---|---|
| 22183MFDS499 | Other Grant/Funding Number | Ministry of Food and Drug Safety (MFDS), Republic of Korea |
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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: medication adherence |
| baseline, 3 month, 6 month |
| Effectiveness: self-efficacy in medication management |
| baseline, 3 month, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Health-related quality of life |
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| Measure | Description | Time Frame |
|---|---|---|
| Implementation: Feasibility of mobile web platform |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University | Recruiting | Seoul | Gwanak-gu | 08826 | South Korea |
The decision not to share individual participant data is based on the potential inclusion of certain personal information in the research data. Furthermore, informed consent was not obtained from participants for the disclosure of their information to third parties or public databases.
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|
| 6 month |
| Effectiveness: Health-related quality of life |
| 6 month |
| Effectiveness: Emergency room visits |
| 6 month |
| Effectiveness: Hospitalizations |
| 6 month |
| 6-month follow-up (intervention group only) |
| Implementation: Usability of mobile web platform |
| 6-month follow-up (intervention group only) |