ClinicalTrials.gov record NCT07212764
Mobile App-Based Infection Monitoring in Familial Mediterranean Fever
Monitoring Infection Symptoms Through a Mobile Application and Their Effect on Disease Flares in Familial Mediterranean Fever Patients
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study asks children and adolescents with Familial Mediterranean Fever to record infection symptoms and FMF attack details in a mobile app. The study will analyze real-time app entries over several months to see how often infection symptoms occur before flares and to assess whether app-based monitoring is practical. No experimental treatment is given.
What it is studying. Whether infection-related symptoms recorded in real time are temporally associated with subsequent FMF attacks, and whether a mobile app is feasible for symptom monitoring.
What the researchers hope to learn. Clarify the timing and association between infection symptoms and FMF flares; measure the correlation between infection symptom frequency and attack frequency; evaluate the feasibility and usability of mobile application–based symptom tracking in routine FMF care.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- mobile application
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Infections are well-recognized triggers of FMF attacks; however, the precise relationship between infection episodes and disease flares remains incompletely understood. Most 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. As a result, the temporal dynamics between infection onset and subsequent FMF flares remain insufficiently characterized. Recent advances in mobile health technologies have created new opportunities to capture disease-related data in real time. Mobile application-based symptom tracking enables patients or caregivers to record clinical events promptly, minimizing recall bias and improving the accuracy and completeness of data collection. This approach facilitates more precise monitoring of the interplay between infections and FMF flares, supports personalized management strategies, and may 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, the study seeks to: clarify the temporal association between infections and FMF flares; assess the clinical impact of infection-triggered flares on disease course; and evaluate the feasibility and usability of mobile application-based symptom tracking in routine FMF care. This study is expected to provide more robust evidence on the infection-flare relationship in FMF, refine clinical decision-making during febrile episodes, and contribute to the integration of digital health tools into the routine management of autoinflammatory diseases.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants (or their caregivers) will use a study mobile application to record infection‑related symptoms (for example fever, cough, nasal discharge, sore throat, myalgia) and any FMF attacks in real time using simple checklists and entry fields. Caregivers may assist with app entries. The information entered will be used by the study team to analyze timing and relationships between infections and FMF flares while participants continue their regular clinic follow-up and treatment. Informed parental/guardian consent and child assent are required.
How the study is structured. A prospective observational cohort study. Participants use a smartphone or tablet app to log infection-related symptoms (for example fever, cough, sore throat) and FMF attacks. Researchers collect and analyze the app data at planned intervals (reported at 3, 6, and 9 months). No treatment is assigned by the study.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in Turkey. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
Important dates
- Study start
- Nov 5, 2025
- Primary completion
- Mar 15, 2026 (estimated)
- Study completion
- Jul 15, 2026 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Dec 3, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Istanbul University
- Principal investigator
- Bengisu Menentoğlu, Principal Investigator
Istanbul University
Participating sites (1)
- Istanbul University Faculty of Medicine
Istanbul, Fatih, 34093 · Turkey (Türkiye)
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- assent
- A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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