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NCT Number: NCT06703697

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

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University

Seoul, Gwanak-gu, 08826, South Korea

Location status: Recruiting

Location contact

Da Eun Lee, Master, Pharm.D

CONTACT

[email protected]

+82 10 9251 9491

Da Eun Lee, Master, Pharm.D

CONTACT

Hyo Joo Jeon, Pharm.D

CONTACT

In-Wha Kim, Master, Ph.D

CONTACT

Ji Sun Chun, Pharm.D

CONTACT

Jung-Mi Oh, Doctor of Pharmacy (Pharm.D)

CONTACT

[email protected]

+82 10 4880 5699

Jung-Mi Oh, Pharm.D

CONTACT

Mari Kim, Pharm.D

CONTACT

Seungyeon Lee, Pharm.D

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: eDrugSafe: mobile web platform

Primary outcomes

  1. 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.
  2. 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.

Secondary outcomes

  1. Effectiveness: Health-related quality of life

    Time frame: 6 month

    • 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.
  2. Effectiveness: Health-related quality of life

    Time frame: 6 month

    • 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.
  3. Effectiveness: Emergency room visits

    Time frame: 6 month

    • Units of Measure: Number of emergency room visits (count)
    • Description: Higher counts reflect poor health outcomes.
  4. Effectiveness: Hospitalizations

    Time frame: 6 month

    • Units of Measure: Number of hospitalizations (count)
    • Description: Higher counts reflect poor health outcomes.

Other outcomes

  1. Implementation: Feasibility of mobile web platform

    Time frame: 6-month follow-up (intervention group only)

    • Assessment: Semi-structured survey guided by the RE-AIM and CFIR frameworks
    • Units of Measure: Descriptive statistics of response frequencies (quantitative data) and qualitative analysis
    • Description: The survey assesses user perspectives across three areas: study background, experience with e-labels and the platform, and potential for adoption. Quantitative data will include descriptive statistics of response frequencies, while qualitative data will be analyzed using word coding to identify themes such as acceptability, adoption, feasibility, and barriers.
  2. Implementation: Usability of mobile web platform

    Time frame: 6-month follow-up (intervention group only)

    • Assessment: Korean System Usability Scale (SUS)
    • Units of Measure: SUS total score (range: 0-100)
    • Description: The SUS is a 10-item tool used to assess the usability of the mobile web platform. Scores range from 0 to 100 and are calculated by adjusting responses and multiplying the total by 2.5. A score above 68 is considered above average for usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Da Eun Lee, Master, Pharm.D

CONTACT

[email protected]

+82 10 9251 9491

Jung-Mi Oh, Pharm.D

CONTACT

[email protected]

+82 10 4880 5699

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Collaborators

  • Ministry of Food and Drug Safety, Korea

Registry information

Official study title

Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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