Inr Tracking Coumadin Use With Phone App

Sponsor

Muhammed Onur Hanedan (Other)

Overall Status

Completed

CT.gov ID

NCT05715541

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Warfarin Mobile Applications	Other: mobile applications with the name "Set My INR"	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of the Knowledge Levels of the Groups on the Use of Coumadin [It ranges from 6 months to 1 year]
To measure the knowledge level with "Patient Information Form" of patients using coumadin about the medication.
Comparison of INR Control and Drug Compliance Values by Groups [It ranges from 6 months to 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi	Trabzon		Turkey	61100

Sponsors and Collaborators

Muhammed Onur Hanedan

Investigators

Principal Investigator: Muhammet Onur HANEDAN, MD, Associate Professor1

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammet Onur HANEDAN, MD, Associate Professor, Muhammed Onur Hanedan

ClinicalTrials.gov Identifier:

NCT05715541

Other Study ID Numbers:

20/01/2021-2021/15-01

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 8, 2023