- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06477068
Effect of a Medication Reminder Mobile Application
Effect of a Medication Reminder Mobile Application on Patients Undergoing Ovarian Stimulation: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ho Chi Minh City, Vietnam, 70000
- Hung Vuong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- BMI > 30.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IVF Patients
Patients undergoes ovarian stimulation for IVF treatment at Hung Vuong Hospital
|
Experimental group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department, in addition to being supported through the "telemedicine medication reminder app on smartphones". Control group: Patients undergoing ovarian stimulation in the Infertility Department at Hung Vuong Hospital are prescribed and instructed to inject medication according to the current procedure of the department. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication non-adherence rate
Time Frame: 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 (%) |
6 months
|
|
Grading on Mobile Application Rating Scale
Time Frame: 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) |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total retrieved oocytes
Time Frame: 6 months
|
The number of oocytes retrieved will be recorded and compared 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. Unit of measure: Count (number) |
6 months
|
|
Total mature oocytes
Time Frame: 6 month
|
The number of retrieved mature oocytes will be recorded and compared 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 Unit of measure: Count (number)
|
6 month
|
|
Total abnormal oocytes
Time Frame: 6 month
|
The number of retrieved abnormal oocytes will be recorded and compared 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 Unit of measure: Count (number)
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Le-Giang Tran, Ph.D., International University, Vietnam National University - Hochiminh City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS/HV/23/29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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