NCT07448181 Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
| NCT ID | NCT07448181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Hereditary Angioedema With C1 Esterase Inhibitor Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-02-23 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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;
Frequently Asked Questions
Who can join the NCT07448181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hereditary Angioedema With C1 Esterase Inhibitor Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07448181 currently recruiting?
Yes, NCT07448181 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituti Clinici Scientifici Maugeri SpA to inquire about joining.
Where is the NCT07448181 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07448181 clinical trial?
NCT07448181 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 30 participants.