Daily phone surveys to track the real-life burden of hereditary angioedema
Official title: Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
Run by Istituti Clinici Scientifici Maugeri SpA · NCT07448181 · Data updated 2026-11-12
The study will try daily phone surveys to see if they reveal a higher and more changeable burden of disease than standard questionnaires in adults with hereditary angioedema.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07448181 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a confirmed diagnosis of HAE Type 1 or Type 2 who can give consent, have a compatible smartphone, and are willing to complete daily surveys for eight weeks are ideal candidates.
✕Probably not a fit
People with acquired or non-C1-INH angioedema, severe cognitive or psychiatric disorders that prevent independent questionnaire completion, children, or those without a compatible smartphone or unwilling to do daily surveys are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project asks adults with confirmed HAE to complete brief digital surveys each day for eight consecutive weeks using the m-Path app, plus standardized questionnaires. The approach uses ecological momentary assessment (EMA) to capture symptoms, mood, and perceived burden in real time rather than relying on memory-based reports. Researchers hypothesize EMA will show greater and more fluctuating burden than retrospective scales and better reflect everyday impact. No experimental treatments are given; the focus is on measurement and understanding patient experience.
Why it matters
Potential benefit: If successful, the approach could provide a more accurate picture of day-to-day burden in HAE and help clinicians and researchers tailor care and outcome measures to patients' real experiences.
How similar studies have gone: Ecological momentary assessment has been used successfully in other chronic illnesses to capture fluctuating symptoms, but its specific application to HAE is limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of Type 1 or Type 2 hereditary angioedema; * Age ≥ 18 years; * Ability to understand instructions and provide informed consent; * Ownership and proficiency in using a personal smartphone compatible with the m-Path application (Android or iOS); * Willingness to participate in the study for the entire duration of the observation period (8 weeks). Exclusion Criteria: * Diagnosis of acquired angioedema or other forms of angioedema unrelated to C1-inhibitor deficiency; * Severe cognitive or psychiatric disorders that compromise the ability to complete the questionnaires independently; * Age \< 18 years;
Where it's running
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Istituti Clinici Scientifici Maugeri, Milan, Milan 20138
Milan, Italy Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.