Mobile App-Based Infection Monitoring in Familial Mediterranean Fever
- Conditions
- Familial Mediterranean Fever (FMF )InfectionMobile Application
- Registration Number
- NCT07212764
- Lead Sponsor
- Istanbul University
- Brief Summary
Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent episodes of fever, abdominal pain, and serositis. FMF attacks often present with fever and systemic symptoms resembling infectious diseases, making it challenging in clinical practice to distinguish between an attack and an infection. Moreover, infections are known to trigger FMF attacks; however, the number of prospective studies evaluating this association remains limited.
In the current literature, the frequency of attacks and triggering factors in FMF patients have mostly been assessed through retrospective chart reviews. Such methods are prone to incomplete or recall-based data regarding the onset of attacks and infection-related symptoms. With the growing availability of digital health applications, it has become possible to record disease symptoms in real time and on a regular basis. This approach provides more reliable data for both clinicians and researchers.
The present study aims to prospectively evaluate the relationship between infections and disease flares in FMF patients by systematically recording infection symptoms and attack characteristics through a mobile application. In this way, we seek to achieve a better understanding of the infection-flare association, improve patient management, and avoid unnecessary treatments. Furthermore, the feasibility of mobile application-based patient monitoring will be assessed, and its potential contribution to routine clinical practice will be explored.
- Detailed Description
Infections are well-recognized triggers of FMF attacks; however, the precise relationship between infection episodes and disease flares remains incompletely understood. The majority of available data on triggering factors have been derived from retrospective chart reviews or patient recall, both of which are prone to incomplete, biased, or delayed reporting. Consequently, our understanding of the temporal dynamics between infection onset and subsequent FMF flares is limited.
Recent advances in mobile health technologies have created new opportunities to capture disease-related data in real time. Mobile application-based symptom tracking allows patients or caregivers to record clinical events promptly, minimizing recall bias and improving the accuracy and completeness of data collection. This approach can facilitate more precise monitoring of the interplay between infections and FMF flares, support personalized management strategies, and potentially reduce unnecessary interventions such as unwarranted antibiotic use or hospitalization.
The present study aims to prospectively evaluate the relationship between infections and disease flares in FMF patients using a dedicated mobile application. By systematically recording infection-related symptoms and attack characteristics in real time, we aim to: Clarify the temporal association between infections and FMF flares. Assess the clinical impact of infection-triggered flares on disease course. Evaluate the feasibility and usability of mobile application-based symptom tracking in routine FMF care.
We anticipate that this study will provide more robust evidence on the infection-flare relationship in FMF, help refine clinical decision-making during febrile episodes, and contribute to the integration of digital health tools into the routine management of autoinflammatory diseases.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of FMF Attacks Preceded by Infection-Related Symptoms Recorded via the Mobile Application 3, 6, 9. months Proportion (%) of FMF attacks that occur within 14 days after the onset of infection-related symptoms (fever ≥38 °C, cough, nasal discharge, sore throat, myalgia, etc.) as recorded by patients or caregivers through the mobile application.
- Secondary Outcome Measures
Name Time Method Correlation Between Frequency of Infection-Related Symptoms and Frequency of FMF Attacks 3,6,9. months Correlation coefficient (Pearson or Spearman, depending on distribution) between the monthly frequency of infection-related symptoms and the monthly frequency of FMF attacks, based on prospectively recorded data in the mobile application.