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Active, Not Recruiting

NCT Number: NCT06933615

Mobile Individual Atrial Fibrillation Management 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Training prepared with mobile application

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Ege University Hospital (Application and Research Center)

Registry information

Official study title

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

Acronym: m-BAFY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Apr 18, 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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