Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
Recruiting now
Conditions studied: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2
In brief
The aim of this study is to conduct an in-depth analysis of the Burden of Disease (BoD) perceived by patients with Hereditary Angioedema (HAE), through daily prospective observations based on Ecological Momentary Assessment (EMA) via digital surveys and standardised questionnaires. Participants will answer online survey questions about their perceived burden of disease for 8 consecutive weeks. The main hypothesis is that daily prospective observation (EMA) will reveal a higher and more fluctuating burden of disease compared to traditional retrospective scales, providing a more accurate representation of the impact of HAE on patients' daily lives.
Key facts
- Study ID
- NCT07448181
- Run by
- Istituti Clinici Scientifici Maugeri SpA
- People needed
- 30
- Starts
- 2026-02-23
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 is running
- Istituti Clinici Scientifici Maugeri, Milan, Milan 20138 — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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