Mobile Individual Atrial Fibrillation Management Program

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06933615
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2024-06-10
• Primary Completion: 2025-01-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study Completion: 2025-04-15
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptom severity assessed by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)	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.
Atrial Fibrillation Impact on Quality of Life Questionnaire (AFEQT)	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.
Self-Care Ability Scale	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.
Medical Adherence Report Scale	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 Izmir, Bornova, Turkey