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Evaluation of Mobile Education Program in Patients With Atrial Fibrillation.

A

Akdeniz University

Status

Not yet enrolling

Conditions

Atrial Fibrillation (AF)

Treatments

Other: Mobile-Atrial Fibrillation Training Program
Other: Routine Outpatient Clinic Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07030335
AU-İHH-SE-01

Details and patient eligibility

About

This study was conducted to determine the effect of a mobile education program and telephone follow-up on the knowledge level, symptom management and quality of life of patients with atrial fibrillation.

The study aims to answer the following questions.

  1. Does the mobile education program and telephone follow-up have an effect on increasing the level of knowledge in patients with AF in the intervention group compared to the control group?
  2. Does the mobile education program and telephone follow-up have an effect on reducing symptom severity in patients with AF in the intervention group compared to the control group?
  3. Does the mobile education program and telephone follow-up have an effect on improving the quality of life in patients with AF in the intervention group compared to the control group?

Full description

The research was planned in two phases: development of the mobile training program and evaluation of its effectiveness. TIn the first phase of the study, M-AFEP (Mobile-Atrial Fibrillation Education Program) application will be developed, and in the second phase of the study, the effectiveness of M-AFEP will be evaluated with a randomized controlled experimental research design with active control group.

The sample of the study will consist of patients diagnosed with AF aged 18 years and older who are followed up for routine controls at the Cardiology Outpatient Clinic of Akdeniz University Hospital and who meet the inclusion criteria.The sample of the study will consist of a total of 70 patients with AF 35 intervention and 35 control groups.

In order to evaluate the comprehensibility of the data collection tools and M-AFEP, it is planned to conduct a four-week pre-application with 4 participants, 10% of the intervention group, before the study. Personal Information Form, Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), The University of Toronto Atrial Fibrillation Severity Scale (AFSS), Effect of Atrial Fibrillation on Quality of Life Scale (AFEQT) and System Usability Scale (SUS) will be used for data collection. Participants in the intervention group, whose consent was obtained, will initially be trained on the use of M-AFEP and the M-AFEP application version will be installed on their phones. Then, the researcher will conduct follow-up by telephone in the first, fourth and eighth weeks. Similarly, a reminder message (sms) about the use of M-AFEP will be sent once a week in the first, fourth and eighth weeks.

Participants will use M-AFEP for twelve weeks. At the end of the twelfth week, patients in the intervention and control groups will complete the post-tests (Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), The University of Toronto Atrial Fibrillation Severity Scale (AFSS), Effect of Atrial Fibrillation on Quality of Life Scale (AFEQT)) using the mobile application. Participants will evaluate the mobile application with the System Usability Scale. These data will constitute the post-test measurements of the study. After the post-test, the M-AFEP application will be shared with the participants in the control group for their benefit.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years of age or older.
  • Being literate.
  • Atrial Fibrillation diagnosis.
  • No cognitive and communication disabilities.
  • Not having a diagnosed psychiatric illness.
  • Ability to use technological devices.
  • Having and using a smart phone with Android operating system and internet access.
  • Acceptance to participate in the study.

Exclusion criteria

  • Diagnosis of rheumatic valve disease, moderate/severe mitral stenosis and previous valve surgery.
  • Functional class III or IV according to the New York Heart Association (NYHA) classification.
  • Patients with existing or planned pacemaker, ICD (Implantable Cardioverter Defibrillator) and patients with existing or planned Radiofrequency Ablation treatment will not be included in the study.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Intervention Group
Experimental group
Treatment:
Other: Mobile-Atrial Fibrillation Training Program
Control Group
Placebo Comparator group
Treatment:
Other: Routine Outpatient Clinic Care

Trial contacts and locations

1

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Central trial contact

Zeynep ÖZER, Prof. Dr. (Professor Doctor); Suna EROĞLU AYGÜL, Lecturer - PhD Student

Data sourced from clinicaltrials.gov

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