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

Condition(s) studied

Investigational drug(s) / intervention(s)

ecological momentary assessment: A real-time data collection method involving brief, repeated digital surveys completed by participants in their natural environments. Participants will receive two notifications every other day for 8 weeks via a mobile application. Surveys are designed to assess physical symptoms, socio-occupational status, and emotional states related to Hereditary Angioedema (HAE) to capture daily fluctuations in disease burden.

Study 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

Primary outcome measure(s)

• Emotional Burden via Ecological Momentary Assessment (EMA) — Every other day for 8 weeks
  Evaluation of emotional states (anxiety, mood, stress, and fear of attacks) through a Visual Analogue Scale (VAS). Each item is scored on a range from 0 to 100, where 0 indicates "no emotional impact" and 100 indicates "maximum emotional distress.
• Socio-occupational Impairment via Ecological Momentary Assessment (EMA) — Every other day for 8 weeks
  Assessment of the impact of Hereditary Angioedema (HAE) on daily, social, and professional activities. Measured via a scale ranging from 1 to 10, where 1 indicates "no impairment" and 10 indicates "maximum perceived impairment"
• Disease Activity — AAS is collected every other day for 8 weeks
  Assessment of the physical burden using the Angioedema Activity Score (AAS): A daily symptom diary, total score from 0 to 15.
• Angioedema Quality of Life — After 4 weeks and at the end of the 8 weeks
  Assessment of quality of life impairment using the AE-QoL questionnaire. The total score ranges from 17 to 85, where higher scores indicate greater impairment.
• Disease Control — After 4 weeks and at the end of the 8 weeks.
  Assessment of disease control using the AECT. The total score ranges from 0 to 16, where lower scores indicate poorer disease control.

Trial sites (1)

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