Mobile HealthNCT06703697
Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe)
A study testing eDrugSafe in people with Mobile Health and Medication Management, run by Seoul National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobile Health, Medication Management, Drug Labelling
- What is being tested?
- eDrugSafe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 79 years.
- Individuals who can speak and understand Korean.
- Possession of a personal electronic device capable of accessing mobile applications and web services over wireless internet (bring participants' own device, BYOD).
- Patients taking three or more medications with at least one medication prescribed for 28 days or longer.
- Individuals who have provided direct consent to participate in the study.
Who cannot join
- Individuals using any mobile web platform other than eDrugSafe for medication safety information purposes after enrollment.
- Individuals who do not consent to participate in the study or who withdraw their consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University
Seoul, Gwanak-gu, 08826
Jung-Mi Oh, Doctor of Pharmacy (Pharm.D), +82 10 4880 5699, jmoh@snu.ac.kr
Da Eun Lee, Master, Pharm.D, +82 10 9251 9491, lde090168@gmail.com
About this study
Official title: Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial
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:
Read more
- 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
- Being tested
- eDrugSafe
- Keywords
- Mobile Health, Medication Management, Drug E-label, electronic labeling, hybrid study, implementation, cluster randomized trial, Electronic Medicinal Product Information (ePI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDrugSafeOther
Also called eDrugSafe: mobile web platform
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: eDrugSafe |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: medication adherence
- Assessment: The Korean version of the Morisky Medication Adherence Scale-8 (MMAS-8)
- Units of Measure: Total MMAS-8 score (range: 0-8)
- Description: The MMAS-8 scale consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score < 6 is considered low adherence, while a total score of ≥ 6 but < 8 indicates moderate adherence, and a score of 8 indicates high adherence.
Measured: baseline, 3 month, 6 month
Effectiveness: self-efficacy in medication management
- Assessment: The Korean version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
- Units of Measure: Total SEAMS score (range: 16-48)
- Description: The SEAMS is a 16-item scale that assesses confidence in managing medications. Higher scores indicate greater self-efficacy and confidence in medication management.
Measured: baseline, 3 month, 6 month
Secondary outcomes (4)
Effectiveness: Health-related quality of life
- Units of Measure: EQ-5D-5L Index (-1 to 1)
- Description: Health-related quality of life at the 6-month follow-up will be assessed using the Korean EQ-5D-5L scale, administered electronically. The EQ-5D-5L measures five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels (no problems to extreme problems). Responses are converted to an index value (1: full health to 0: death; below 0: worse than death) using a validated Korean scoring algorithm.
Measured: 6 month
Effectiveness: Health-related quality of life
- Units of Measure: EQ-5D-5L VAS Score (0 to 100)
- Description: Health-related quality of life at the 6-month follow-up will be assessed using the Korean EQ-5D-5L scale, administered electronically. A Visual Analogue Scale (VAS) will also measure self-rated health on a scale from 0 (worst) to 100 (best), administered concurrently with the EQ-5D-5L.
Measured: 6 month
Effectiveness: Emergency room visits
- Units of Measure: Number of emergency room visits (count)
- Description: Higher counts reflect poor health outcomes.
Measured: 6 month
Effectiveness: Hospitalizations
- Units of Measure: Number of hospitalizations (count)
- Description: Higher counts reflect poor health outcomes.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start12 Aug 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Principal investigator, Jung Mi Oh, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703697
- Sponsor's protocol ID
- SNUH IRB 2403_002-015
- Other IDs
- 22183MFDS499
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06703697
- Acronym / sponsor ID
- SNUH IRB 2403_002-015
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: eDrugSafe | Experimental | Other: eDrugSafeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 79 years.
- Individuals who can speak and understand Korean.
- Possession of a personal electronic device capable of accessing mobile applications and web services over wireless internet (bring participants' own device, BYOD).
- Patients taking three or more medications with at least one medication prescribed for 28 days or longer.
- Individuals who have provided direct consent to participate in the study.
Key exclusion criteria (2 listed)
- Individuals using any mobile web platform other than eDrugSafe for medication safety information purposes after enrollment.
- Individuals who do not consent to participate in the study or who withdraw their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eDrugSafeAlso: eDrugSafe: mobile web platformThe 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 group: eDrugSafe |
Primary outcome
Effectiveness: medication adherence
Time frame: baseline, 3 month, 6 month
* Assessment: The Korean version of the Morisky Medication Adherence Scale-8 (MMAS-8) * Units of Measure: Total MMAS-8 score (range: 0-8) * Description: The MMAS-8 scale consists of 8 items. Each of the first 7 items has 2 possible responses (yes/no), while the 8th item is answered with a 5-point Likert scale. The possible total medication adherence score ranges between 0 and 8, and the higher the score, the better the adherence level. A total score < 6 is considered low adherence, while a total score of ≥ 6 but < 8 indicates moderate adherence, and a score of 8 indicates high adherence.
Effectiveness: self-efficacy in medication management
Time frame: baseline, 3 month, 6 month
* Assessment: The Korean version of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) * Units of Measure: Total SEAMS score (range: 16-48) * Description: The SEAMS is a 16-item scale that assesses confidence in managing medications. Higher scores indicate greater self-efficacy and confidence in medication management.
4 secondary outcomes
Effectiveness: Health-related quality of life
Time frame: 6 month
Effectiveness: Health-related quality of life
Time frame: 6 month
Effectiveness: Emergency room visits
Time frame: 6 month
Effectiveness: Hospitalizations
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eDrugSafe in people with Mobile Health and Medication Management, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Mi Oh, Pharm.D (+82 10 4880 5699, jmoh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: medication adherence (time frame: baseline, 3 month, 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.