WarfarinNCT05715541
Inr Tracking Coumadin Use With Phone App
A study testing mobile applications with the name "Set My INR" in people with Warfarin and Mobile Applications, run by Muhammed Onur Hanedan at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the INR values of the patients followed by face-to-face and telephone applications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Warfarin, Mobile Applications
- What is being tested?
- mobile applications with the name "Set My INR"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old, using a smartphone, not having a psychiatric illness or treatment, and agreeing to participate
Who cannot join
- requiring medical examination, not using a smartphone, having a psychiatric illness or treatment, and not agreeing to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Trabzon, 61100
About this study
Official title: 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.
Read the 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
- Being tested
- mobile applications with the name "Set My INR"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applications with the name "Set My INR"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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: mobile applications with the name "Set My INR" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: It ranges from 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jun 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WarfarinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammed Onur Hanedan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Onur HANEDAN, Muhammed Onur Hanedan
- Investigators
- Muhammet Onur HANEDAN, Principal investigator, MD, Associate Professor1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715541
- Sponsor's protocol ID
- 20/01/2021-2021/15-01
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inr Tracking With Face-To-Face And Phone App: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05715541
- Acronym / sponsor ID
- 20/01/2021-2021/15-01
- Conditions
- Warfarin, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Muhammed Onur HanedanUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of INR Control and Drug Compliance Values by Groups | Other | Other: mobile applications with the name "Set My INR"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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 18 years old, using a smartphone, not having a psychiatric illness or treatment, and agreeing to participate
Key exclusion criteria (1 listed)
- requiring medical examination, not using a smartphone, having a psychiatric illness or treatment, and not agreeing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Comparison of INR Control and Drug Compliance Values by Groups |
Primary outcome
Comparison of the Knowledge Levels of the Groups on the Use of Coumadin
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammet Onur HANEDAN principal investigator
MD, Associate Professor1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile applications with the name "Set My INR" in people with Warfarin and Mobile Applications, run by Muhammed Onur Hanedan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Knowledge Levels of the Groups on the Use of Coumadin (time frame: It ranges from 6 months to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.