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

Recruitingn/aAges 18 Years - anyAllIstituti Clinici Scientifici Maugeri SpA
NCT07448181 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • ecological momentary assessment
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Where

1 site
Istituti Clinici Scientifici Maugeri, Milan, Milan 20138
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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