Mobile App-Based Infection Monitoring in Familial Mediterranean Fever (NCT07212764) | Clinical Trial Compass
By InvitationNot Applicable
Mobile App-Based Infection Monitoring in Familial Mediterranean Fever
Turkey (Türkiye)40 participantsStarted 2025-11-05
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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
Exclusion Criteria
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of FMF Attacks Preceded by Infection-Related Symptoms Recorded via the Mobile Application