Completed

NCT Number: NCT02757482

Patient Training About the Safety of Warfarin Therapy

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.

Completed

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Key information

Conditions

Warfarin Knowledge Level International Normalized Ratio Control Patient Training

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CELAL BAYAR UNIVERSITY Ö.Y.P. (Teaching Staff Training Program) OFFICE

Manisa, Muradiye, 45140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Other

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

Effects of Patient Training About the Safety of Warfarin Therapy on the Patients' Warfarin Knowledge Level and International Normalized Ratio Control (INR)

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 2, 2016
Registry last updated: May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.