Effect of a Medication Reminder Mobile Application on Patients Undergoing Ovarian Stimulation: A Prospective Non-Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 2
- 主要终点
- Medication non-adherence rate
研究概览
简要总结
The goal of this clinical trial is to evaluate of effectiveness when using the "telemedicine medication reminder app on smartphones" at the Infertility Department of Hung Vuong Hospital. The main questions it aims to answer are:
Comparison of the medication forgetting rate between the group of patients using the product and the group of patients not using the app.
Assessment of the level of patient satisfaction when using the app. Comparison of the quantity and quality outcomes of eggs between the group of patients using the app and the group of patients not using the app.
Participants will:
Using or not using " "telemedicine medication reminder app on smartphones" Record the number of cycle cancellations, number of missed doses, satisfaction rates, number of retrieved oocytes, number of mature oocytes, number of immature oocytes, and number of abnormal oocytes.
详细描述
Goal of SMART:
S Specific: fertility specialists at the Infertility Department of Hung Vuong Hospital, researchers at the Department of Biomedical Engineering - International University - National University of Ho Chi Minh City, and patients at the Infertility Department of Hung Vuong Hospital. Fertility specialists will be responsible for advising and assisting the research team in developing the "telemedicine medication reminder app on smartphones" tailored to the needs and user-friendly for patients. They will support data collection to compare the effectiveness of product usage. Researchers will be responsible for developing and improving the "telemedicine medication reminder app on smartphones" according to the requirements of fertility specialists and patients, as well as analyzing data to evaluate the product's effectiveness.
M Measurable: The effectiveness of the "telemedicine medication reminder app on smartphones" will be compared between the group of patients using the product and the group of patients not using it: Comparison of the medication forgetting rate between the group of patients using the product and the group of patients not using the product.
Evaluation of patient satisfaction level when using the product. Comparison of the quantity and quality outcomes of eggs between the group of patients using the product and the group of patients not using the product.
A Attainable: The Department of Biomedical Engineering has developed numerous telemedicine healthcare products and achieved notable successes, exemplified by the telemedicine blood pressure monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To eliminate factors that may affect egg quality, we selected patients with good prognosis for the study (18-< 40 years old, undergoing IVF treatment for the first time).
- •Indicated for ovarian stimulation for IVF treatment.
- •Be able to use a smartphone.
- •No underlying diseases: Diabetes mellitus, Increased prolactin, Thyroid dysfunction, and Adrenal disorders.
- •Voluntary participate in the study and agree to sign the consent form.
排除标准
- •IVF patient with oocyte donation.
- •Reduced ovarian reserve.
- •Contraindications for using ovarian stimulation drugs.
- •Endocrine or metabolic disorders, any underlying diseases (kidney, liver, or heart disease).
- •Subjects unwilling to participate in the study.
- •Patients who are unable to comply with the study protocol: not using a smartphone, missing appointments for follow-up visits, unable to read or write in Vietnamese.
研究组 & 干预措施
Control arm
IVF Patients
Patients undergoes ovarian stimulation for IVF treatment at Hung Vuong Hospital
干预措施: Mobile medical reminder application (Combination Product)
结局指标
主要结局
Medication non-adherence rate
时间窗: 6 months
Comparison of the medication non-adherence rate (in percentage) between the group of IVF patients using the mobile medical reminder application and the group of IVF patients not using the mobile medical reminder application. The adherence outcome was the participant-level occurrence of at least 1 missed medication dose during ovarian stimulation.
Grading on Mobile Application Rating Scale
时间窗: 6 months
Assessment of the mobile medical reminder application quality will be graded following the Mobile Application Rating Scale (MARS). MARS includes a set of questions that are graded by users. Users will rate the app on a scale from 1 to 5. The average MARS score will be used. Unit of measure: Quality score (MARS)
次要结局
- Total abnormal oocytes(6 month)
- Total retrieved oocytes(6 months)
- Total mature oocytes(6 month)
- Grading on Mobile Application Rating Scale(6 months)
- Degenerated/nonviable oocytes(6 month)
研究者
Thi Thanh Thuy Tran, MD
Hung Vuong Hospital
Hung Vuong Hospital