Evaluation of Mobile Education Program in Patients With Atrial Fibrillation.

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT07030335
• Lead Sponsor: Akdeniz University

Brief Summary

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?

Detailed 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.

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2025-07
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Jessa Atrial Fibrillation Knowledge Questionnaire	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.
The University of Toronto Atrial Fibrillation Severity Scale	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.
Effect of Atrial Fibrillation on Quality of Life Scale	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 Outcome Measures

Name	Time	Method
System Usability Scale-SUS	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.

Trial Locations

Locations (1)

Akdeniz University Hospital Cardiology Polyclinic; 🇹🇷 Antalya, Konyaaltı, Turkey