Evaluation of Mobile Education Program in Patients With Atrial Fibrillation.

June 12, 2025 updated by: Suna Eroğlu Aygül, Akdeniz University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07070
        • Akdeniz University Hospital Cardiology Polyclinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Mobile-Atrial Fibrillation Training Program
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.
Placebo Comparator: Control Group
Other: Routine Outpatient Clinic Care
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurement will be done at the end of the study (at the end of the 12th week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

June 12, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-İHH-SE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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