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Recruiting NCT07448181

Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema

Trial Parameters

Condition Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
Sponsor Istituti Clinici Scientifici Maugeri SpA
Study Type OBSERVATIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02-23
Completion 2027-02-28
Interventions
ecological momentary assessment

Brief Summary

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.

Eligibility 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;

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