Evaluating the Effectiveness and Implementation of Mobile Health Platform for Medication Management and E-Labeling (eDrugSafe): a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Effectiveness: medication adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: eDrugSafe (Other)
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.
结局指标
主要结局
Effectiveness: medication adherence
时间窗: 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
时间窗: 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.
次要结局
- Effectiveness: Emergency room visits(6 month)
- Effectiveness: Hospitalizations(6 month)
- Effectiveness: Health-related quality of life(6 month)
研究者
Jung Mi Oh
Professor
Seoul National University