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Patient Training About the Safety of Warfarin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02757482
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
Tülay SAĞKAL MİDİLLİ, Asistant professor, Celal Bayar University

Brief Summary:
The purpose of this study is to examine the effects of patient training about the safety of warfarin therapy on related knowledge levels and on International Normalized Ratio (INR) control.

Condition or disease Intervention/treatment Phase
Warfarin Knowledge Level International Normalized Ratio Control Patient Training Other: training Not Applicable

Detailed Description:

Although warfarin is widely used in the treatment and prophylaxis of thromboembolic diseases, it is an oral anticoagulant with serious adverse effects. Therefore, the patient must be informed about its safe use.

A patient's level of knowledge concerning the drug plays a key role in the effective and safe use of warfarin. In the Joint Commission International (JCI) National Patient Safety Goal (NPSG) guideline for 2014 education on treatment for patients taking oral anticoagulants was recognized as a vital factor. Previous studies have reported that a positive relationship between patients' anticoagulant knowledge levels and the INR number in the therapeutic range.

For this reason there is a need for effective education programs to increase patients' knowledge concerning warfarin and to keep it up to date. Education and information services provided to patients using anticoagulants will reduce the costs of treatment by reducing risks such as thromboembolism and bleeding. When planning education, individual characteristics and needs must be kept in mind, and group education in addition to individual sessions and the use of written and visual material will increase the effectiveness of the education.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of Patient Training About the Safety of Warfarin Therapy on the Patients' Warfarin Knowledge Level and International Normalized Ratio Control (INR)
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin

Arm Intervention/treatment
Experimental: intervention
Patient training
Other: training
No Intervention: control
no patient training

Primary Outcome Measures :
  1. Warfarin Knowledge Level Measurement [ Time Frame: 2 months ]
    Warfarin knowledge level was measured by The Warfarin Knowledge Assessment Form. This form consisted of 30 questions. These questions covered basic information for drug treatment such as the drug dose, the duration of drug use, adverse effects of the drug, drug-drug and drug-food interaction, drug use in pregnancy, dental care and treatment, laboratory monitoring, exercise and diet. Each correct answer scored 1, and each wrong answer or a 'don't know' response scored 0. The last two questions in the last section on drug use related to pregnancy and nursing a child, and so these were answered only by women. Patients' raw information scores were between 0 and 30. Those scoring 0-15 were accepted as having a low level of information, those scoring 16-21 a moderate level, and those scoring 22-30 a high level of information.

Secondary Outcome Measures :
  1. International Normalized Ratio Measurements [ Time Frame: 6 months ]
    The last three INR measurement values for the two patient groups were taken from the hospital records and recorded, together with the INR values for the day of the first interview. The warfarin knowledge evaluation form was applied again to the patients of each group in the first and second months, and the INR values for those dates were obtained from hospital records.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Using warfarin for at least two months,
  • Between 18 and 65 years old,
  • Were literate,
  • Not have a structured education about warfarin

Exclusion Criteria:

  • Have structured education about warfarin,
  • Have a seeing or hearing disability,
  • Have a cognitive or sensory disorder,
  • Have a disability affecting oral communication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02757482

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CELAL BAYAR UNIVERSITY Ö.Y.P. (Teaching Staff Training Program) OFFICE
Manisa, Muradiye, Turkey, 45140
Sponsors and Collaborators
Celal Bayar University
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Study Director: TULAY SAGKAL MIDILLI, Phd, RN Assistant professor
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Responsible Party: Tülay SAĞKAL MİDİLLİ, Asistant professor, Asistant Professor, Celal Bayar University Identifier: NCT02757482    
Other Study ID Numbers: CBU-2015-02
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tülay SAĞKAL MİDİLLİ, Asistant professor, Celal Bayar University:
Patient training
International Normalized Ratio