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ENROLLING BY INVITATION
NCT07212764

Mobile App-Based Infection Monitoring in Familial Mediterranean Fever

Sponsor: Istanbul University

View on ClinicalTrials.gov

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.

Official title: Monitoring Infection Symptoms Through a Mobile Application and Their Effect on Disease Flares in Familial Mediterranean Fever Patients

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-11-05

Completion Date

2026-07-15

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (1)

Istanbul University Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)