The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

NCT ID: NCT02871765

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Patient education related Warfarin

Intervention Type 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.

control group

The control group received the brochure only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YU-HSIA TSAI, MS,RN

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

References

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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.

Reference Type BACKGROUND
PMID: 18566863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18275605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16004677 (View on PubMed)

Other Identifiers

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98-3227B

Identifier Type: -

Identifier Source: org_study_id

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