Inr Tracking Coumadin Use With Phone App

NCT ID: NCT05715541

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-11-30

Brief Summary

This study aims to compare the INR values of the patients followed by face-to-face and telephone applications.

Detailed Description

Warfarin has a narrow therapeutic window. Maintaining the patient's international normalized ratio (INR) within the predefined therapeutic range is one of the main challenges of warfarin treatment. This study was designed as a randomized controlled experiment. Twelve patients living in a distant place were assigned to the experimental group, and 12 patients living nearby and followed in the outpatient clinic were assigned to the control group. A Patient Information Form and the Adherence to Refills and Medications Scale were used to collect data.

Conditions

Warfarin; Mobile Applications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Comparison of INR Control and Drug Compliance Values by Groups

Follow-up of the patients in the control group continued in the outpatient clinic.

This application includes an interface where patients can enter drug treatment information such as INR values, disease diagnosis, how many times a day and how many mg they take, and a chat box section where they can communicate with their physicians, including emergencies. The doctor reviewed the patient's INR findings once they were relayed by the patient, then told them to adjust the patient's warfarin dosage and schedule the next INR check. The application sent notifications to the patients every day about when and how many mg of the drug they would take

Group Type: OTHER

mobile applications with the name "Set My INR"

Intervention Type: OTHER

The relevant software company assisted in developing the phone application. The language of the application created with the name "Set My INR" is Turkish. The application provided an opportunity for patients to share and communicate with their physician after having the INR value measured in a health institution near their place of residence before coming to the hospital

Interventions

mobile applications with the name "Set My INR"

The relevant software company assisted in developing the phone application. The language of the application created with the name "Set My INR" is Turkish. The application provided an opportunity for patients to share and communicate with their physician after having the INR value measured in a health institution near their place of residence before coming to the hospital

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• at least 18 years old, using a smartphone, not having a psychiatric illness or treatment, and agreeing to participate

Exclusion Criteria

• requiring medical examination, not using a smartphone, having a psychiatric illness or treatment, and not agreeing to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammed Onur Hanedan

OTHER

Sponsor Role: lead

Responsible Party

Muhammet Onur HANEDAN

MD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammet Onur HANEDAN

Role: PRINCIPAL_INVESTIGATOR

MD, Associate Professor1

Locations

Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20/01/2021-2021/15-01

Identifier Type: -

Identifier Source: org_study_id