The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Patient education related Warfarin

• Registration Number: NCT02871765
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-07
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Study First Posted: 2016-08-18
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
education group	Patient education related Warfarin	In education group, each subject in the experimental group was taught individually according to investigator's brochure in the outpatient department by researchers. Three months later, participants in the education group received a follow-up phone call in order to clarify any questions related to the brochure. All participants completed posttest at 6-month follow-up.

Primary Outcome Measures

Name	Time	Method
knowledge of Warfarin	6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
quality of life	6-month follow-up	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.
life distress	6-month follow-up	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.