Mobile App-Based Infection Monitoring in Familial Mediterranean Fever

NCT07212764 | Enrolling By Invitation

• 1 other identifier: Fmf-Enfeksiyon
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Familial Mediterranean Fever (FMF ); Infection; Mobile Application

Keywords

familial mediterranean fever; mobile application; infection disease

Outcome Measures

Primary Outcomes (1)

• Proportion of FMF Attacks Preceded by Infection-Related Symptoms Recorded via the Mobile Application

  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.

  3, 6, 9. months

Secondary Outcomes (1)

• Correlation Between Frequency of Infection-Related Symptoms and Frequency of FMF Attacks

  3,6,9. months

Study Arms (1)

FMF group

Patients aged 6-18 years with a diagnosis of FMF according to the Tel Hashomer and Eurofever criteria who agreed to use the mobile application

Other: mobile application

Interventions

mobile application OTHER

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.

FMF group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include children and adolescents aged 6-18 years with a diagnosis of Familial Mediterranean Fever (FMF) according to the Tel Hashomer and/or Eurofever criteria. Participants will be under regular follow-up at the pediatric rheumatology clinic and agree to record infection-related symptoms and FMF complaints through a mobile application. Patients with comorbid chronic inflammatory, autoimmune, or immunodeficiency disorders will be excluded. Informed consent from parents/legal guardians and assent from the child will be obtained.

You may qualify if:

• Children and adolescents aged 8-18 years
• FMF diagnosis established by Tel Hashomer and/or Eurofever criteria
• Regular follow-up at the participating pediatric rheumatology clinic
• Stable treatment regimen, defined as:
• Colchicine use for ≥ 4 weeks
• Biologic or other anti-inflammatory agents stable for ≥ 8 weeks (if applicable)
• Access to a smartphone or tablet (iOS/Android) with internet and ability to use the study mobile application (caregiver assistance allowed)
• Language proficiency (patient and/or caregiver) sufficient to use the app and respond to prompts
• Informed consent from a parent/guardian and assent from the child, as appropriate

You may not qualify if:

• Co-existing chronic inflammatory or autoimmune disorders that may confound flare/infection assessment (e.g., JIA, IBD, Behçet disease) other than FMF
• Known primary or secondary immunodeficiency or ongoing immunosuppressive chemotherapy outside standard FMF care
• Chronic active infection (e.g., TB, HBV, HCV, HIV) or acute febrile illness at enrollment precluding baseline assessment
• Cognitive, visual, or motor limitations preventing app use without caregiver support
• No reliable access to a compatible device or internet connection
• Concurrent participation in another clinical study likely to affect outcomes or reporting
• Anticipated non-adherence (e.g., inability to complete app entries) as judged by the investigator
• Refusal or withdrawal of consent/assent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Mediterranean Fever; Infections

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bengisu Menentoğlu

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 8, 2025
• Study Start: November 5, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)