Actively Recruiting
Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-03-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the daily burden experienced by patients with Hereditary Angioedema (HAE), a rare genetic disorder causing unpredictable swelling attacks that can affect various body parts and impact quality of life in many ways. This study aims to capture a more accurate and dynamic understanding of how HAE affects patients by using real-time digital surveys and standardized questionnaires over an 8-week period, rather than relying on traditional retrospective assessments that may miss daily fluctuations and emotional impacts. Participants will use a smartphone app to complete brief digital surveys every other day for 8 weeks. These surveys ask about physical symptoms, social and work-related challenges, and emotional states related to HAE. The study uses Ecological Momentary Assessment (EMA), which collects data in real life and reduces recall bias. Standard questionnaires measuring angioedema activity, quality of life, and disease control will also be completed at 4 and 8 weeks. During the study, participants will answer online surveys that assess emotional burden, socio-occupational impairment, disease activity, anxiety, depression, and work productivity. Researchers will analyze these real-time data along with traditional questionnaire results to better understand how the burden of HAE fluctuates day by day. The study will monitor participants for 8 weeks, with repeated assessments to capture detailed patterns of disease impact and emotional well-being.
CONDITIONS
Brief Title
Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Type 1 or Type 2 hereditary angioedema
- Age 18 years or older
- 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 will not qualify if you...
- 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 under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 8 weeks
Participants complete brief digital surveys via a mobile app every other day for 8 weeks to report physical symptoms, socio-occupational status, and emotional states related to Hereditary Angioedema in real time.
Two survey notifications every other day for 8 weeks
Duration - 8 weeks
Participants complete additional questionnaires weekly or biweekly to assess anxiety, depressive symptoms, work productivity, and quality of life during the 8-week observation period.
Weekly and biweekly digital questionnaires for 8 weeks
Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri, Milan, Milan 20138
Milan, Italy, 20138
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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