NCT05145634

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable atrial-fibrillation

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

July 23, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

health education programhealth belief modelinformative technologyanticoagulantsatrial fibrillationrandomized controlled study

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

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.

Other: Patient education related oral anticoagulants (OACs)

Control group

NO INTERVENTION

Patients 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.

Educational group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Hsia Tsai

    Chang Gung University

    PRINCIPAL INVESTIGATOR

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