Clinical trial NCT06933615: Mobile Individual Atrial Fibrillation Management Program
Official title: Development and Evaluation of the Effectiveness of a Mobile Individual Atrial Fibrillation Management (m-BAFY) Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: atrial fibrillation
mobile health
nursing care
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Ege University Hospital (Application and Research Center)
First posted: 2025-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The universe will consist of all patients diagnosed with AF who apply to the Arrhythmia Polyclinic of the Cardiology Department of Ege University Health Application and Research Center. The sample will consist of patients selected from the universe and who meet the inclusion criteria for the study. Power analysis was performed to determine the number of patients to be included in the study. The power of the test was calculated with the G. Power-3.1.9.2 program. The effect size (d= 0.544) of a similar study in the relevant literature regarding the change in AF-specific quality of life was taken as basis (Woo et al., 2022). Based on this; with an alpha value of 0.05, an effect size of 0.544, and a theoretical power of 0.90, the minimum sample size in the intervention group was calculated as 45 people in total. The groups within the scope of the study were divided into two groups, the intervention group and the control group, using the stratified randomization method.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom severity assessed by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
timeFrame: Baseline, at the end of four weeks and at the end of twelve weeks
measure: Atrial Fibrillation Impact on Quality of Life Questionnaire (AFEQT)
timeFrame: Baseline, at the end of four weeks and at the end of twelve weeks
measure: Self-Care Ability Scale
timeFrame: Baseline, at the end of four weeks and at the end of twelve weeks
measure: Medical Adherence Report Scale
timeFrame: Baseline, at the end of four weeks and at the end of twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References: