NCT05715541

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 18, 2023

Last Update Submit

January 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Comparison of INR Control and Drug Compliance Values by Groups

OTHER

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"

Interventions

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

Comparison of INR Control and Drug Compliance Values by Groups

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Trabzon, 61100, Turkey (Türkiye)

Location

Study Officials

  • Muhammet Onur HANEDAN

    MD, Associate Professor1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 8, 2023

Study Start

June 1, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

No: There is not a plan to make IPD available.

Locations