The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Atrial Fibrillation Clinical Trial

Official title:

The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871765
• Other study ID #: 98-3227B
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: August 15, 2016
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate an educational program for Atrial Fibrillation patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life distresses and quality of life.

Description:

This is a parallel-group randomized controlled study. Four measurements were (a) knowledge of Warfarin; (b) life distresses caused by Warfarin treatment; and (c) quality of life as primary and secondary endpoint. All participants participated in a face-to-face interview during the pretest and at the 6-month follow-up in the outpatient department (OPD). Each subject in the experimental group was taught face-to-face individually according to investigator's brochure in the OPD by researchers trained in a standardized protocol. The control group received a brochure only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Atrial Fibrillation by a physician and taking Warfarin as treatment

• 20 years old or older

• clear consciousness for communication

• willingness to participate in research

Exclusion Criteria:

• can not communicate clearly

• without willingness to participate in research

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Patient education related Warfarin
Patient education related Warfarin: each subject in the experimental group was taught individually according to investigator's brochure in the outpatient department (OPD) by researchers. Three months later, participants received a follow-up phone call in order to clarify any questions related to the brochure. The contents of the brochure consisted of: the purpose of taking Warfarin, side effects, adjustments to daily diet, and precautions (i.e. how to take medication safely, interaction between foods and medicine, prevention and checking of signs and symptoms of bleeding). The control group received the brochure after pretest and routine care only in the OPD. All participants completed posttest at 6-month follow-up.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (3)

Casais P, Meschengieser SS, Sanchez-Luceros A, Lazzari MA. Patients' perceptions regarding oral anticoagulation therapy and its effect on quality of life. Curr Med Res Opin. 2005 Jul;21(7):1085-90. — View Citation

Pernod G, Labarère J, Yver J, Satger B, Allenet B, Berremili T, Fontaine M, Franco G, Bosson JL. EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study. J Gen Intern Med. 2008 Sep;23(9):1441-6. doi: 10.1007/s11606-008-0690-1. Epub 2008 Jun 20. — View Citation

Wofford JL, Wells MD, Singh S. Best strategies for patient education about anticoagulation with warfarin: a systematic review. BMC Health Serv Res. 2008 Feb 14;8:40. doi: 10.1186/1472-6963-8-40. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge of Warfarin	There were six questions and the contents were consistent with investigator's brochure used in investigator's research setting. When participants answered questions correctly, or illustrated at least two correct examples for each item, participants received one point; otherwise, participants received no point. The range of scores was 0-6. The higher the score, the better the patient's knowledge of Warfarin was.	6-month follow-up	No
Secondary	life distress	There were six questions. The most commonly cited things patients suffered from while under Warfarin treatment were included. When participants answered "yes", participants received one point; if participants answered "no", participants received no point. The range of scores was 0-6. A higher score indicated a worse life distresses.	6-month follow-up	No
Secondary	quality of life	Investigators use SF-36 to measure participants' quality of life.The SF-36 consists of eight scaled scores, including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health,which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.	6-month follow-up	No