Familial Mediterranean Fever (FMF )NCT07212764
Mobile App-Based Infection Monitoring in Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever (FMF ) and Infection, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF ), Infection, Mobile Application
- What is being tested?
- mobile application
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2025to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: Monitoring Infection Symptoms Through a Mobile Application and Their Effect on Disease Flares in Familial Mediterranean Fever Patients
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.
Read the detailed description
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.
- Being tested
- mobile application
- Keywords
- familial mediterranean fever, mobile application, infection disease
- Medical subject headings
- Familial Mediterranean Fever, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applicationOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, 9. months
Secondary outcomes (1)
Correlation Between Frequency of Infection-Related Symptoms and Frequency of FMF Attacks
Correlation coefficient (Pearson or Spearman, depending on distribution) between the monthly frequency of infection-related symptoms and the monthly frequency of FMF attacks, based on prospectively recorded data in the mobile application.
Measured: 3,6,9. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start5 Nov 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengisu Menentoğlu, Istanbul University
- Investigators
- Bengisu Menentoğlu, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212764
- Sponsor's protocol ID
- Fmf-Enfeksiyon
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Infection Symptoms Through a Mobile Application and Their Effect on Disease Flares in Familial Mediterranean Fever Patients
- ClinicalTrials.gov ID
- NCT07212764
- Acronym / sponsor ID
- Fmf-Enfeksiyon
- Keywords
- familial mediterranean fever, mobile application, infection disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMF group | – | Other: mobile applicationPatients aged 6-18 years with a diagnosis of FMF according to the Tel Hashomer and Eurofever criteria who agreed to use the mobile application |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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
- Colchicine use for ≥ 4 weeks
- Biologic or other anti-inflammatory agents stable for ≥ 8 weeks (if applicable)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile applicationPatients 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. | Other | FMF group |
Primary outcome
Proportion of FMF Attacks Preceded by Infection-Related Symptoms Recorded via the Mobile Application
Time frame: 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.
1 secondary outcome
Correlation Between Frequency of Infection-Related Symptoms and Frequency of FMF Attacks
Time frame: 3,6,9. months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bengisu Menentoğlu principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever (FMF ) and Infection, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of FMF Attacks Preceded by Infection-Related Symptoms Recorded via the Mobile Application (time frame: 3, 6, 9. months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.