Inr Tracking Coumadin Use With Phone App

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

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

Study Overview

• Status: Completed
• Conditions: Mobile Applications; Warfarin
• Intervention / Treatment: Other: mobile applications with the name "Set My INR"

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61100
    • Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Muhammed Onur Hanedan
• Investigators: Principal Investigator: Muhammet Onur HANEDAN, MD, Associate Professor1

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20/01/2021-2021/15-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No