Atrial Fibrillation (AF)m-BAFYNCT06933615
Mobile Individual Atrial Fibrillation Management Program
A study testing Training prepared with mobile application in people with Atrial Fibrillation (AF), run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Training prepared with mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hearing and speech problems
- Cardiac surgery < 3 months before the interview date
- Presence of psychiatric disease
- No data entry for at least 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Training prepared with mobile application
- Keywords
- atrial fibrillation, mobile health, nursing care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training prepared with mobile applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | 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. |
| The mobile application group | Experimental | 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. Receives: Other: Training prepared with mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity assessed by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
The scale contains three sections, "AF Burden", "Healthcare Use" and "AF Symptom Severity", and a total of 19 items.
Measured: Baseline, at the end of four weeks and at the end of twelve weeks
Atrial Fibrillation Impact on Quality of Life Questionnaire (AFEQT)
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.
Measured: Baseline, at the end of four weeks and at the end of twelve weeks
Self-Care Ability Scale
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.
Measured: Baseline, at the end of four weeks and at the end of twelve weeks
Medical Adherence Report Scale
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.
Measured: Baseline, at the end of four weeks and at the end of twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start10 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University Hospital (Application and Research Center)
- Responsible party
- Principal investigator, Adile Ay, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933615
- Sponsor's protocol ID
- Aay
- Acronym
- m-BAFY
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of a Mobile Individual Atrial Fibrillation Management (m-BAFY) Program
- ClinicalTrials.gov ID
- NCT06933615
- Acronym / sponsor ID
- m-BAFY / Aay
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, mobile health, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Ege University Hospital (Application and Research Center)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –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. |
| The mobile application group | Experimental | Other: Training prepared with mobile applicationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Hearing and speech problems
- Cardiac surgery < 3 months before the interview date
- Presence of psychiatric disease
- No data entry for at least 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training prepared with mobile applicationThe 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. | Other | The mobile application group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training prepared with mobile application in people with Atrial Fibrillation (AF), run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.