The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

August 15, 2016 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: education group
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
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.
No Intervention: control group
The control group received the brochure only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month follow-up
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.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: YU-HSIA TSAI, MS,RN, Chang Gung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-3227B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators are going to publish research results.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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