The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

NCT02871765 | Completed DMC

• 1 other identifier: 98-3227B
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Patient education; Knowledge; Life distress; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• life distress

  6-month follow-up

• quality of life

  6-month follow-up

Study Arms (2)

education group

EXPERIMENTAL

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

control group

NO INTERVENTION

The control group received the brochure only.

Interventions

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.

education group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Atrial Fibrillation by a physician and taking Warfarin as treatment
• years old or older
• clear consciousness for communication
• willingness to participate in research

You may not qualify if:

• can not communicate clearly
• without willingness to participate in research

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (3)

• Pernod G, Labarere J, Yver J, Satger B, Allenet B, Berremili T, Fontaine M, Franco G, Bosson JL. EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study. J Gen Intern Med. 2008 Sep;23(9):1441-6. doi: 10.1007/s11606-008-0690-1. Epub 2008 Jun 20.

  PMID: 18566863 BACKGROUND

• Wofford JL, Wells MD, Singh S. Best strategies for patient education about anticoagulation with warfarin: a systematic review. BMC Health Serv Res. 2008 Feb 14;8:40. doi: 10.1186/1472-6963-8-40.

  PMID: 18275605 BACKGROUND

• Casais P, Meschengieser SS, Sanchez-Luceros A, Lazzari MA. Patients' perceptions regarding oral anticoagulation therapy and its effect on quality of life. Curr Med Res Opin. 2005 Jul;21(7):1085-90. doi: 10.1185/030079905X50624.

  PMID: 16004677 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• YU-HSIA TSAI, MS,RN

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 18, 2016
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 18, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share