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临床试验/NCT06477068
NCT06477068
已完成
不适用

Effect of a Medication Reminder Mobile Application on Patients Undergoing Ovarian Stimulation: a Randomized Controlled Trial

Hung Vuong Hospital2 个研究点 分布在 1 个国家目标入组 387 人2024年5月22日

概览

阶段
不适用
干预措施
Mobile medical reminder application
疾病 / 适应症
Infertility
发起方
Hung Vuong Hospital
入组人数
387
试验地点
2
主要终点
Medication non-adherence rate
状态
已完成
最后更新
3天前

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. The Infertility Department has a policy to foster scientific research collaboration, aiming to enhance treatment effectiveness and patient satisfaction. The Infertility Department is a prominent and reputable reproductive support center with a large number of patients, facilitating data collection needs. R Realistic: The demand for remote monitoring and home healthcare is a legitimate need for patients, especially following the COVID-19 pandemic. T Time-bound: This research will be conducted over a period of 18 months with specific tasks including 10 months for mobile application development, 6 months for patients recruitment and 2 months for data analysis and interpretation.

注册库
clinicaltrials.gov
开始日期
2024年5月22日
结束日期
2026年4月22日
最后更新
3天前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Thi Thanh Thuy Tran, MD

Hung Vuong Hospital

Hung Vuong Hospital

入排标准

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

IVF Patients

Patients undergoes ovarian stimulation for IVF treatment at Hung Vuong Hospital

干预措施: Mobile medical reminder application

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 medication non-adherence rate is calculated as the number of times the medication was forgotten divided by the total number of prescribed medication doses. Unit of measure: Percentage (%)

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)

研究点 (2)

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