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NCT Number: NCT07030335

Evaluation of Mobile Education Program in Patients With Atrial Fibrillation.

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Hospital Cardiology Polyclinic

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location contact

Suna EROĞLU AYGÜL, Lecturer- Phd Student

CONTACT

[email protected]

+090 242 227 45 37 ext. 2893

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile-Atrial Fibrillation Training Program

Other

Patient Information Form, Atrial Fibrillation Information Scale, Atrial Fibrillation Severity Scale and Atrial Fibrillation Impact on Quality of Life Questionnaire will be administered face-to-face by the researcher using Mobile Atrial Fibrillation Education Program (M-AFEP). The application link, individual e-mail and user passwords will be sent to the mobile phones of the participants and the application will be added to the main screens by entering the relevant address from their phones. Participants will be asked to use M-AFEP for twelve weeks / at least ten minutes a week and the frequency and duration of use will be recorded on the mobile application. Participants in the intervention group will be followed up by phone once a week in the first, fourth and eighth weeks and a reminder message (sms) will be sent for the use of M-AFEP. At the end of the twelfth week, the scales will be filled in again through the application.

Routine Outpatient Clinic Care

Other
  • Participants in the control group will be given M-AFEP application usage training by the researchers.
  • The application link, individual e-mail and user passwords will be sent to the mobile phones of the participants in the control group.
  • Participants in the control group will enter the relevant address of the mobile application from their phones and the application will be added to their home screens.
  • In the M-AFEP application of the participants in the control group, there will be a short general information section containing information specific to AF, different from the intervention group content.

Participants in the control group will continue only routine outpatient follow-up throughout the process and no intervention will be applied.

Primary outcomes

  1. The Jessa Atrial Fibrillation Knowledge Questionnaire

    Time frame: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

    -The Jessa Atrial Fibrillation Knowledge Questionnaire- will be used to assess participants' knowledge about their AAF condition. The scale consists of a total of 16 items and 3 sub-dimensions. The lowest score to be obtained from the scale is "0" and the highest score is "16". The higher the score obtained from the scale, the higher the patient's level of knowledge.

  2. The University of Toronto Atrial Fibrillation Severity Scale

    Time frame: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

    The University of Toronto Atrial Fibrillation Severity Scale is a scale that will be used to assess the severity of AF-specific disease, the burden it creates in individuals and the frequency of AF episodes. The scale consists of 19 items and 3 sections. Higher scores indicate greater AF burden and more severe symptoms.

  3. Effect of Atrial Fibrillation on Quality of Life Scale

    Time frame: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

    Effect of Atrial Fibrillation on Quality of Life Scale consists of four sub dimensions and 20 questions measuring the quality of life of patients with AF. Scoring of the scale ranges from 0 to 100 in general and sub-dimension scores. A score of zero indicates that quality of life is negatively affected.

Secondary outcomes

  1. System Usability Scale-SUS

    Time frame: Measurement will be done at the end of the study (at the end of the 12th week).

    There are a total of 10 items in the System Usability Scale. Each item in the scale takes a value between 1 and 5. A total System Usability Scale score ranging from 0-100 is obtained. According to this score, systems or interfaces can be evaluated in terms of usability. The higher the score, the more usable the system is.

Study contacts

Contact information is provided by the study sponsor or research team.

Suna EROĞLU AYGÜL, Lecturer - PhD Student

CONTACT

[email protected]

+90 242 227 45 37 ext. 2893

Zeynep ÖZER, Prof. Dr. (Professor Doctor)

CONTACT

[email protected]

+90 242 310 6126 ext. 6126

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

The Effect Of A Mobıle Educatıon Program and Telephone Follow-Up On Knowledge Level, Symptom Management And Qualıty Of Lıfe In Patıents Wıth Atrıal Fıbrıllatıon

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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