Atrial FibrillationNCT05145634
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
A study testing Patient education related oral anticoagulants (OACs) in people with Atrial Fibrillation, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Patient education related oral anticoagulants (OACs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- can not communicate clearly
- without willingness to participate in research
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Patient education related oral anticoagulants (OACs)
- Keywords
- health education program, health belief model, informative technology, anticoagulants, atrial fibrillation, randomized controlled study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education related oral anticoagulants (OACs)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational group | Experimental | 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. Receives: Other: Patient education related oral anticoagulants (OACs) |
| Control group | No intervention | Patients in the control group only received brochure and medication cards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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"
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.
Measured: 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"
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2014
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsia Tsai, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145634
- Sponsor's protocol ID
- 103-5623B
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05145634
- Acronym / sponsor ID
- 103-5623B
- Conditions
- Atrial Fibrillation
- Keywords
- health education program, health belief model, informative technology, anticoagulants, atrial fibrillation, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational group | Experimental | Other: Patient education related oral anticoagulants (OACs)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. |
| Control group | No intervention | –Patients in the control group only received brochure and medication cards. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- can not communicate clearly
- without willingness to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education related oral anticoagulants (OACs)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. | Other | Educational group |
Primary outcome
The change of "medication knowledge of anticoagulants"
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
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"
Time frame: health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
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.
2 secondary outcomes
The change of "medication satisfaction of anticoagulants"
Time frame: 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"
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- BackgroundKonieczynska, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsia Tsai principal investigator
Chang Gung University
Questions about this trial
What is this clinical trial studying?
A study testing Patient education related oral anticoagulants (OACs) in people with Atrial Fibrillation, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of "medication knowledge of anticoagulants" (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05145634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.