The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
This study examined patients on taking oral anticoagulants (OACs) are often prescribed for Atrial fibrillation (AFib) to determine the effectiveness of a multiple interactive health education program, which was developed based on the health belief model (HBM) and incorporated information technologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Dec 2014
Typical duration for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedFirst Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedDecember 6, 2021
July 1, 2021
3.2 years
July 23, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The change of "medication knowledge of anticoagulants"
There were 11 questions related to knowledge of anticoagulants designed by investigators' research team. The range of scores was 0-22. The higher the score, the better the participants' knowledge of anticoagulants was.
medication knowledge of anticoagulants was assessed at baseline, change from baseline medication knowledge of anticoagulants at 2 months, and change from baseline medication knowledge of anticoagulants at 3 months
The change of "health beliefs of anticoagulants"
There were 22 questions related to health beliefs of anticoagulants designed by investigators' research team. The range of scores was 0-88. The higher the score, the better the participants' health beliefs was.
health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
Secondary Outcomes (2)
The change of "medication satisfaction of anticoagulants"
medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
The change of "quality of life for patients taking anticoagulants"
quality of life for patients taking anticoagulants was assessed at baseline, and change from baseline quality of life for patients taking anticoagulants at 3 months
Study Arms (2)
Educational group
EXPERIMENTALThe interventions administered to the experimental group were one-on-one instruction and Health Brief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
Control group
NO INTERVENTIONPatients in the control group only received brochure and medication cards.
Interventions
The interventions administered to the experimental group were one-on-one instruction and Health Belief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards. Patient education related oral anticoagulant: each subject in the experimental group was taught individually according to investigators' App in the outpatient department (OPD) by researchers. Every months, participants received a follow-up phone call to clarify any questions related to the knowledge of anticoagulants. The contents of the teaching material consisted of: the purpose of taking anticoagulant, 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 and medical card after pretest and routine care in the OPD. All participants completed posttest at 3-month follow-up.
Eligibility Criteria
You may qualify if:
- diagnosis of Atrial Fibration by a physician and taking oral anticoagulant 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Konieczynska, M., Sobieraj, E., Bryk, A. H., Debski, M., Polak, M., Podolec, P., . . . Undas, A. (2018). Differences in knowledge among patients with atrial fibrillation receiving NOACs and vitamin K antagonists. Kardiol Pol. doi:10.5603/KP.a2018.0069 Morrissey, E. C., Casey, M., Glynn, L. G., Walsh, J. C., & Molloy, G. J. (2018). Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence, 12, 813-822. Stephenson, J. J., Shinde, M. U., Kwong, W. J., Fu, A. C., Tan, H., & Weintraub, W. S. (2018). Comparison of claims vs patient-reported adherence measures and associated outcomes among patients with nonvalvular atrial fibrillation using oral anticoagulant therapy. Patient Prefer Adherence, 12, 105-117.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Hsia Tsai
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2021
First Posted
December 6, 2021
Study Start
December 1, 2014
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
December 6, 2021
Record last verified: 2021-07