Mobile App-Based Infection Monitoring in Familial Mediterranean Fever

Condition(s) studied

Investigational drug(s) / intervention(s)

mobile application: Patients will be instructed to record any symptoms suggestive of infectious diseases-such as fever, cough, nasal discharge, or myalgia-directly into the mobile application whenever they occur. The app will provide simple checklists and entry fields, allowing patients (or their caregivers) to promptly log these symptoms in real time. By systematically documenting infection-related manifestations alongside routine follow-up data, it will be possible to prospectively evaluate whether infectious episodes act as potential triggers for Familial Mediterranean Fever (FMF) attacks. The collected data will then be analyzed to determine temporal and clinical associations between infection symptoms and subsequent disease flares, thereby clarifying whether infections precipitate or overlap with FMF attacks.

Study 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, providing 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. This approach is intended to achieve a better understanding of the infection-flare association, improve patient management, and prevent unnecessary treatments. In addition, the feasibility of mobile application-based patient monitoring will be assessed, and its potential contribution to routine clinical practice will be explored.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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