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The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02871765
Enrollment
122
Registered
2016-08-18
Start date
2010-01-31
Completion date
2010-12-31
Last updated
2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Patient education, Knowledge, Life distress, Quality of life

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.

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.

Interventions

OTHERPatient 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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
knowledge of Warfarin6-month follow-upThere 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

MeasureTime frameDescription
life distress6-month follow-upThere 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 life6-month follow-upInvestigators 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026