Mobile Individual Atrial Fibrillation Management Program (m-BAFY)

April 10, 2025 updated by: Adile Ay, Ege University

Development and Evaluation of the Effectiveness of a Mobile Individual Atrial Fibrillation Management (m-BAFY) Program

The aim of the study is to develop a mobile individual atrial fibrillation management (m-BAFY) program and to evaluate the effects of the program on symptom severity, medication compliance, self-care agency and quality of life. The main questions that the study aims to answer are as follows;

  • Is the m-BAFY program effective in symptom control?
  • Is the m-BAFY program effective in increasing medication compliance?
  • Is the m-BAFY program effective in improving self-care agency?
  • Is the m-BAFY program effective in improving quality of life? In order to measure whether m-BAFY is effective, the researchers will download this application to one group's phones, and the other group will not download the application.

Participants;

  • Use this application for 3 months
  • Patients in the intervention group use the application at least once every two weeks.
  • Fill in the symptom diary in the application.
  • Clinical interviews are called for the first interview, at the end of the 1st month and at the end of the 3rd month.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The research sample was divided into two groups, the intervention and control groups, using the simple randomization method. The m-BAFY program prepared for the intervention group will be downloaded to their phones and asked to use it for three months. A unique username and password will be created for each patient. Patients' records and navigation between tabs will be tracked via the Firebase system. Motivational messages and feedback will be given to patients. Patients will be informed that they will be provided with consultancy services within the scope of the program content throughout the research.

The standard program of the clinic will be applied to the patients in the control group. No intervention will be made by the researcher. Follow-up data will be collected by the researcher at the end of the 1st and 3rd months using the tools in the data collection form.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35030
        • Ege University

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:

  • Being 18 years old and above
  • Having an AF diagnosis
  • Being literate
  • Being able to understand and speak Turkish
  • Being able to use a smartphone
  • Being willing to participate in the study

Exclusion Criteria:

  • Hearing and speech problems
  • Cardiac surgery < 3 months before the interview date
  • Presence of psychiatric disease
  • No data entry for at least 2 weeks

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care Group
The standard program of the clinic will be applied to the patients in the control group. No intervention will be made by the researcher. Follow-up data will be collected by the researcher at the first interview and at the end of the 1st and 3rd months using the tools included in the data collection form. At the end of the research, the m-BAFY program will be shared with the patients in the control group.
Experimental: The mobile application group
Patients in the intervention mobile application group are downloaded to their mobile phones. This application includes information about the patient's disease. Motivational and condition-related messages are sent to their phones.
Other: Training prepared with mobile application
The m-BAFY program will be loaded onto the mobile phones of patients in the mobile application group. Each patient will be informed on how to use the mobile program. In addition, a short training will be given on how to use the application. With this application, the symptoms and vital signs recorded by the patients will be monitored and individual feedback will be provided. Information on the management of the disease prepared in line with the guidelines is included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity assessed by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Time Frame: Baseline, at the end of four weeks and at the end of twelve weeks
The scale contains three sections, "AF Burden", "Healthcare Use" and "AF Symptom Severity", and a total of 19 items.
Baseline, at the end of four weeks and at the end of twelve weeks
Atrial Fibrillation Impact on Quality of Life Questionnaire (AFEQT)
Time Frame: Baseline, at the end of four weeks and at the end of twelve weeks
The scale consists of 20 items in four sub-dimensions: symptoms, daily activities, treatment anxiety/concern, and treatment satisfaction. A score of zero indicates that the quality of life is negatively affected, while a score of 100 indicates that the quality of life is not negatively affected.
Baseline, at the end of four weeks and at the end of twelve weeks
Self-Care Ability Scale
Time Frame: Baseline, at the end of four weeks and at the end of twelve weeks
The scale consists of 35 items. Each statement is scored from 0 to 4 and answered on a 5-point Likert-type scale. It is ranked as 0 (does not describe me at all), 1 (does not describe me very much), 2 (I have no idea), 3 (describes me a little), 4 (describes me very much). As the score increases, the self-care ability of the patients increases in direct proportion.
Baseline, at the end of four weeks and at the end of twelve weeks
Medical Adherence Report Scale
Time Frame: Baseline, at the end of four weeks and at the end of twelve weeks
It contains five items related to medication compliance. Each item is evaluated on a 5-point Likert type scale where "5=never, 4=rarely, 3=sometimes, 2=often and 1=very often". The lowest score that can be obtained from the scale is 5, and the highest is 25. It is stated that as the score obtained increases, medication compliance increases, and as the score decreases, medication compliance decreases.
Baseline, at the end of four weeks and at the end of twelve weeks

Collaborators and Investigators

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

Sponsor

Ege University

Collaborators

Ege University Hospital (Application and Research Center)

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 (Actual)

June 10, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aay

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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