The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient education related oral anticoagulants (OACs)
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring health education program, health belief model, informative technology, anticoagulants, atrial fibrillation, randomized controlled study
Eligibility Criteria
Inclusion Criteria:
- diagnosis of Atrial Fibration by a physician and taking oral anticoagulant as treatment
- 20years old or older
- clear consciousness for communication
- willingness to participate in research.
Exclusion Criteria:
- can not communicate clearly
- without willingness to participate in research
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational group
Control group
Arm Description
The 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.
Patients in the control group only received brochure and medication cards.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The change of "medication satisfaction of anticoagulants"
There were 26 questions related to medication satisfaction of anticoagulants (Duke Anticoagulation Satisfaction Scale, DASS). The range of scores was 1-182. The lower the score, the better the participants' medication satisfaction was.
The change of "quality of life for patients taking anticoagulants"
There were 12 questions related to quality of life for patients taking anticoagulants (Short Form-12, SF-12). The range of scores was 0-100 transferred in each question. The higher the score, the better the participants' quality of life was.
Full Information
NCT ID
NCT05145634
First Posted
July 23, 2021
Last Updated
November 22, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05145634
Brief Title
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
Official Title
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
A randomized controlled study was conducted on the cardiology outpatients. The patients were recruited through purposive sampling. The participants had been diagnosed with AFib and were receiving OACs. The participants were divided according to the blocks of clinic hours and assigned randomly to the experimental group or control group. The control variables involved demographic characteristics and medical history. The dependent variables and corresponding research instruments were medication knowledge and health beliefs, medication satisfaction and quality of life (QoL). Other than the medication knowledge questionnaire, which was assessed monthly, all the measurement instruments were applied twice: first in a pretest, and again in a posttest administered at the third month. The interventions administered to the experimental group were one-on-one instruction and HBM-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards. The participants in the control group only received brochure and medication cards.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
health education program, health belief model, informative technology, anticoagulants, atrial fibrillation, randomized controlled study
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational group
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group only received brochure and medication cards.
Intervention Type
Other
Intervention Name(s)
Patient education related oral anticoagulants (OACs)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of "medication knowledge of anticoagulants"
Description
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.
Time Frame
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
Title
The change of "health beliefs of anticoagulants"
Description
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.
Time Frame
health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
Secondary Outcome Measure Information:
Title
The change of "medication satisfaction of anticoagulants"
Description
There were 26 questions related to medication satisfaction of anticoagulants (Duke Anticoagulation Satisfaction Scale, DASS). The range of scores was 1-182. The lower the score, the better the participants' medication satisfaction was.
Time Frame
medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
Title
The change of "quality of life for patients taking anticoagulants"
Description
There were 12 questions related to quality of life for patients taking anticoagulants (Short Form-12, SF-12). The range of scores was 0-100 transferred in each question. The higher the score, the better the participants' quality of life was.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of Atrial Fibration by a physician and taking oral anticoagulant as treatment
20years old or older
clear consciousness for communication
willingness to participate in research.
Exclusion Criteria:
can not communicate clearly
without willingness to participate in research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsia Tsai
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
Learn more about this trial
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
We'll reach out to this number within 24 hrs