The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Patient education related Warfarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: education group<br>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. | Other: Patient education related Warfarin<br>* 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.<br>|
| No Intervention: control group<br>The control group received the brochure only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient education, Knowledge, Life distress, Quality of life