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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 23, 2021
    Last Updated
    November 22, 2021
    Sponsor
    Chang Gung Memorial Hospital
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    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
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    The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant

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