Patient Training About the Safety of Warfarin Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Warfarin Knowledge Level; International Normalized Ratio Control; Patient Training
• Intervention / Treatment: Other: training

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muradiye
    • Manisa, Muradiye, Turkey, 45140
      • CELAL BAYAR UNIVERSITY Ö.Y.P. (Teaching Staff Training Program) OFFICE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Patient training	Other: training
No Intervention: control; no patient training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Warfarin Knowledge Level Measurement	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Normalized Ratio Measurements	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.	6 months

Collaborators and Investigators

• Sponsor: Celal Bayar University
• Investigators: Study Director: TULAY SAGKAL MIDILLI, Phd, RN, Assistant Professor

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 24, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Nursing; Warfarin; International Normalized Ratio; Patient training
• Other Study ID Numbers: CBU-2015-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided