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Atrial Fibrillation (AF)NCT07030335

Evaluation of Mobile Education Program in Patients With Atrial Fibrillation.

A study testing Mobile-Atrial Fibrillation Training Program and Routine Outpatient Clinic Care in people with Atrial Fibrillation (AF), run by Akdeniz University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study was conducted to determine the effect of a mobile education program and telephone follow-up on the knowledge level, symptom management and quality of life of patients with atrial fibrillation. The study aims to answer the following questions. 1. 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?
Mobile-Atrial Fibrillation Training Program and Routine Outpatient Clinic Care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
Jun 2025to Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 18 years of age or older.
  • Being literate.
  • Atrial Fibrillation diagnosis.
  • No cognitive and communication disabilities.
  • Not having a diagnosed psychiatric illness.
  • Ability to use technological devices.
  • Having and using a smart phone with Android operating system and internet access.
  • Acceptance to participate in the study.

Who cannot join

  • Diagnosis of rheumatic valve disease, moderate/severe mitral stenosis and previous valve surgery.
  • Functional class III or IV according to the New York Heart Association (NYHA) classification.
  • Patients with existing or planned pacemaker, ICD (Implantable Cardioverter Defibrillator) and patients with existing or planned Radiofrequency Ablation treatment will not be included in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suna EROĞLU AYGÜL, Lecturer - PhD Student contact

+90 242 227 45 37 ext. 2893

sunaeroglu@akdeniz.edu.tr

Zeynep ÖZER, Prof. Dr. (Professor Doctor) contact

+90 242 310 6126 ext. 6126

zeynepcanli@akdeniz.edu.tr

Turkey (Türkiye)1 site
  • Akdeniz University Hospital Cardiology Polyclinic

    Antalya, Konyaaltı, 07070

    Suna EROĞLU AYGÜL, Lecturer- Phd Student, +090 242 227 45 37 ext. 2893, sunaeroglu@akdeniz.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of A Mobıle Educatıon Program and Telephone Follow-Up On Knowledge Level, Symptom Management And Qualıty Of Lıfe In Patıents Wıth Atrıal Fıbrıllatıon

This study was conducted to determine the effect of a mobile education program and telephone follow-up on the knowledge level, symptom management and quality of life of patients with atrial fibrillation.

The study aims to answer the following questions.

  1. Does the mobile education program and telephone follow-up have an effect on increasing the level of knowledge in patients with AF in the intervention group compared to the control group?
  2. Does the mobile education program and telephone follow-up have an effect on reducing symptom severity in patients with AF in the intervention group compared to the control group?
  3. Does the mobile education program and telephone follow-up have an effect on improving the quality of life in patients with AF in the intervention group compared to the control group?
Read the detailed description

The research was planned in two phases: development of the mobile training program and evaluation of its effectiveness. TIn the first phase of the study, M-AFEP (Mobile-Atrial Fibrillation Education Program) application will be developed, and in the second phase of the study, the effectiveness of M-AFEP will be evaluated with a randomized controlled experimental research design with active control group.

The sample of the study will consist of patients diagnosed with AF aged 18 years and older who are followed up for routine controls at the Cardiology Outpatient Clinic of Akdeniz University Hospital and who meet the inclusion criteria.The sample of the study will consist of a total of 70 patients with AF 35 intervention and 35 control groups.

In order to evaluate the comprehensibility of the data collection tools and M-AFEP, it is planned to conduct a four-week pre-application with 4 participants, 10% of the intervention group, before the study. Personal Information Form, Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), The University of Toronto Atrial Fibrillation Severity Scale (AFSS), Effect of Atrial Fibrillation on Quality of Life Scale (AFEQT) and System Usability Scale (SUS) will be used for data collection. Participants in the intervention group, whose consent was obtained, will initially be trained on the use of M-AFEP and the M-AFEP application version will be installed on their phones. Then, the researcher will conduct follow-up by telephone in the first, fourth and eighth weeks. Similarly, a reminder message (sms) about the use of M-AFEP will be sent once a week in the first, fourth and eighth weeks.

Participants will use M-AFEP for twelve weeks. At the end of the twelfth week, patients in the intervention and control groups will complete the post-tests (Jessa Atrial Fibrillation Knowledge Questionnaire (JAKQ), The University of Toronto Atrial Fibrillation Severity Scale (AFSS), Effect of Atrial Fibrillation on Quality of Life Scale (AFEQT)) using the mobile application. Participants will evaluate the mobile application with the System Usability Scale. These data will constitute the post-test measurements of the study. After the post-test, the M-AFEP application will be shared with the participants in the control group for their benefit.

Being tested
Mobile-Atrial Fibrillation Training Program, Routine Outpatient Clinic Care
Keywords
Atrial Fibrillation, Nursing, Mobile application, Symptom management, Quality of life, Level of knowledge
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile-Atrial Fibrillation Training ProgramOther

    Patient Information Form, Atrial Fibrillation Information Scale, Atrial Fibrillation Severity Scale and Atrial Fibrillation Impact on Quality of Life Questionnaire will be administered face-to-face by the researcher using Mobile Atrial Fibrillation Education Program (M-AFEP). The application link, individual e-mail and user passwords will be sent to the mobile phones of the participants and the application will be added to the main screens by entering the relevant address from their phones. Participants will be asked to use M-AFEP for twelve weeks / at least ten minutes a week and the frequency and duration of use will be recorded on the mobile application. Participants in the intervention group will be followed up by phone once a week in the first, fourth and eighth weeks and a reminder message (sms) will be sent for the use of M-AFEP. At the end of the twelfth week, the scales will be filled in again through the application.

  • Routine Outpatient Clinic CareOther

    • Participants in the control group will be given M-AFEP application usage training by the researchers.
    • The application link, individual e-mail and user passwords will be sent to the mobile phones of the participants in the control group.
    • Participants in the control group will enter the relevant address of the mobile application from their phones and the application will be added to their home screens.
    • In the M-AFEP application of the participants in the control group, there will be a short general information section containing information specific to AF, different from the intervention group content.

    Participants in the control group will continue only routine outpatient follow-up throughout the process and no intervention will be applied.

Study groups in NCT07030335
Study groupRoleWhat they receive
Intervention GroupExperimentalNot described
Receives: Other: Mobile-Atrial Fibrillation Training Program
Control GroupPlacebo comparatorNot described
Receives: Other: Routine Outpatient Clinic Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Jessa Atrial Fibrillation Knowledge Questionnaire

    -The Jessa Atrial Fibrillation Knowledge Questionnaire- will be used to assess participants' knowledge about their AAF condition. The scale consists of a total of 16 items and 3 sub-dimensions. The lowest score to be obtained from the scale is "0" and the highest score is "16". The higher the score obtained from the scale, the higher the patient's level of knowledge.

    Measured: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

  2. The University of Toronto Atrial Fibrillation Severity Scale

    The University of Toronto Atrial Fibrillation Severity Scale is a scale that will be used to assess the severity of AF-specific disease, the burden it creates in individuals and the frequency of AF episodes. The scale consists of 19 items and 3 sections. Higher scores indicate greater AF burden and more severe symptoms.

    Measured: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

  3. Effect of Atrial Fibrillation on Quality of Life Scale

    Effect of Atrial Fibrillation on Quality of Life Scale consists of four sub dimensions and 20 questions measuring the quality of life of patients with AF. Scoring of the scale ranges from 0 to 100 in general and sub-dimension scores. A score of zero indicates that quality of life is negatively affected.

    Measured: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.

Secondary outcomes (1)
  1. System Usability Scale-SUS

    There are a total of 10 items in the System Usability Scale. Each item in the scale takes a value between 1 and 5. A total System Usability Scale score ranging from 0-100 is obtained. According to this score, systems or interfaces can be evaluated in terms of usability. The higher the score, the more usable the system is.

    Measured: Measurement will be done at the end of the study (at the end of the 12th week).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030335
Sponsor's protocol ID
AU-İHH-SE-01
Status last verified
Jun 2025
First submitted
27 May 2025
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Allan KS, Aves T, Henry S, Banfield L, Victor JC, Dorian P, Healey JS, Andrade JG, Carroll SL, McGillion MH. Health-Related Quality of Life in Patients With Atrial Fibrillation Treated With Catheter Ablation or Antiarrhythmic Drug Therapy: A Systematic Review and Meta-analysis. CJC Open. 2020 Apr 2;2(4):286-295. doi: 10.1016/j.cjco.2020.03.013. eCollection 2020 Jul.

    PubMed 32695978
  • Guo Y, Chen Y, Lane DA, Liu L, Wang Y, Lip GYH. Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial. Am J Med. 2017 Dec;130(12):1388-1396.e6. doi: 10.1016/j.amjmed.2017.07.003. Epub 2017 Aug 26.

    PubMed 28847546
  • Smigorowsky MJ, Norris CM, McMurtry MS, Tsuyuki RT. Measuring the effect of nurse practitioner (NP)-led care on health-related quality of life in adult patients with atrial fibrillation: study protocol for a randomized controlled trial. Trials. 2017 Aug 3;18(1):364. doi: 10.1186/s13063-017-2111-4.

    PubMed 28774317
  • Palm P, Qvist I, Rasmussen TB, Christensen SW, Hakonsen SJ, Risom SS. Educational interventions to improve outcomes in patients with atrial fibrillation-a systematic review. Int J Clin Pract. 2020 Nov;74(11):e13629. doi: 10.1111/ijcp.13629. Epub 2020 Sep 7.

    PubMed 32726511
  • Pearsons A, Hanson CL, Gallagher R, O'Carroll RE, Khonsari S, Hanley J, Strachan FE, Mills NL, Quinn TJ, McKinstry B, McHale S, Stewart S, Zhang M, O'Connor S, Neubeck L. Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. Eur J Cardiovasc Nurs. 2021 May 22;20(4):305-314. doi: 10.1093/eurjcn/zvaa014.

    PubMed 33620473
  • Willems S, Borof K, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Gessler N, Goette A, Haegeli LM, Heidbuchel H, Kautzner J, Ng GA, Schnabel RB, Suling A, Szumowski L, Themistoclakis S, Vardas P, van Gelder IC, Wegscheider K, Kirchhof P. Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial. Eur Heart J. 2022 Mar 21;43(12):1219-1230. doi: 10.1093/eurheartj/ehab593.

    PubMed 34447995
  • Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.

    PubMed 38033089
  • Boriani G, Vitolo M, Diemberger I, Proietti M, Valenti AC, Malavasi VL, Lip GYH. Optimizing indices of atrial fibrillation susceptibility and burden to evaluate atrial fibrillation severity, risk and outcomes. Cardiovasc Res. 2021 Jun 16;117(7):1-21. doi: 10.1093/cvr/cvab147.

    PubMed 33913486
  • Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.

    PubMed 39210723

Questions about this trial

What is this clinical trial studying?

A study testing Mobile-Atrial Fibrillation Training Program and Routine Outpatient Clinic Care in people with Atrial Fibrillation (AF), run by Akdeniz 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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jun 2025. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suna EROĞLU AYGÜL, Lecturer - PhD Student (+90 242 227 45 37 ext. 2893, sunaeroglu@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Jessa Atrial Fibrillation Knowledge Questionnaire (time frame: The measurement will be done at the beginning of the study (day 0) and at the end of the 12th week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030335, which also lists 9 linked publications.

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 22 Jun 2025.

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