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The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

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ClinicalTrials.gov Identifier: NCT02871765
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Patient education related Warfarin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871765


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: YU-HSIA TSAI, MS,RN Chang Gung University

Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02871765     History of Changes
Other Study ID Numbers: 98-3227B
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators are going to publish research results.
Keywords provided by Chang Gung Memorial Hospital:
Patient education
Knowledge
Life distress
Quality of life
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants