Hereditary angioedema (HAE) multi-national survey study

Burden of hereditary angioedema (HAE) and impact on quality of life: a multi-national survey of patients and caregivers

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN85479564

Enrollment

750

Registered

2022-10-31

Start date

2022-08-01

Completion date

Unknown

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary angioedema quality of life for patients and caregivers Circulatory System

Interventions

ICON, on behalf of Takeda, is conducting an online survey assessing the quality of life of patients with hereditary angioedema and their caregivers. The HAE multi-national survey study

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Self-reported diagnosis of HAE (Types I, II, normal functioning C1-INH, or unknown type) 2. Age 18 years or older 3. Experienced at least 1 episode of angioedema or prodromal symptoms within the last year 4. Has been treated with a prescription medication for an angioedema attack within the last 2 years 5. Able to understand and provide consent 6. Willing to complete an web-based survey 7. Adequate fluency in the target language in which the survey is designed: 7.1. Spanish (Argentina & Colombia) 7.2. Brazilian Portuguese (Brazil) 7.3. Croatian (Croatia) 7.4. Danish (Denmark) 7.5. Hungarian (Hungary) 7.6. English (Ireland) 7.7. Norwegian (Norway) 7.8. Polish (Poland) 7.9. Portuguese (Portugal) 7.10. Romanian (Romania) 7.11. Swedish (Sweden)

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Measured using an online survey at a single time point: 1. Perceived control of angioedema measured with the Angioedema Control Test (AECT) 2. Quality of Life measured with the Angioedema Quality-of-Life Questionnaire (AE-QoL) 3. Work impacts measured with the Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH) 4. Overall health measured with the Medical Outcomes Study Short Form 12-Item Questionnaire (SF-12) 5. Anxiety and Depression measured with the Hospital Anxiety and Depression Scale (HADS) 6. De novo questions about HAE attacks, medications used, and life impacts of the condition	—

Measure

Time frame

Measured using an online survey at a single time point: 1. Perceived control of angioedema measured with the Angioedema Control Test (AECT) 2. Quality of Life measured with the Angioedema Quality-of-Life Questionnaire (AE-QoL) 3. Work impacts measured with the Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH) 4. Overall health measured with the Medical Outcomes Study Short Form 12-Item Questionnaire (SF-12) 5. Anxiety and Depression measured with the Hospital Anxiety and Depression Scale (HADS) 6. De novo questions about HAE attacks, medications used, and life impacts of the condition

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Argentina, Brazil, Colombia, Croatia, Denmark, Germany, Hungary, Ireland, Norway, Poland, Portugal, Romania, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026