Inr Tracking Coumadin Use With Phone App

Mobile Applications Clinical Trial

Official title:

Inr Tracking With Face-To-Face And Phone App: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05715541
• Other study ID #: 20/01/2021-2021/15-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Muhammed Onur Hanedan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mobile Applications
• Warfarin

Intervention

Other:
• 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

Locations

Country	Name	City	State
Turkey	Ahi Evren Gögüs Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Muhammed Onur Hanedan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Knowledge Levels of the Groups on the Use of Coumadin	To measure the knowledge level with "Patient Information Form" of patients using coumadin about the medication.	It ranges from 6 months to 1 year
Primary	Comparison of INR Control and Drug Compliance Values by Groups	Measuring medication compliance with "The Adherence to Refills and Medications Scale" of patients using coumadin.; To compare the INR values of the patients using the phone application and followed face to face.	It ranges from 6 months to 1 year