The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Patient education related Warfarin

Other

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.

Primary outcomes

knowledge of Warfarin

Time frame: 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 outcomes

life distress

Time frame: 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.
quality of life

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Aug 18, 2016
Registry last updated: Aug 18, 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.

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Completed