Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema (BESQAOH)

8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec.

Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)

Study Overview

• Status: Completed
• Conditions: Hereditary Angioedema
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • CHUGA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with HAE with or without C1 inhibitor deficiency

Description

Inclusion Criteria:

• Patient with HAE with or without C1 inhibitor deficiency
• Patient over 15 or parents of a child under 15 with HAE

Exclusion Criteria:

• Patient opposed to the use of their data or refusing to answer the questionnaire
• Adult patients protected by law

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
angiodema hereditary patients; Patient with HAE with or without C1 inhibitor deficiency will respond to an electronic questionnaire	Other: questionnaire; electronic questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE)	questionnaire To know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE)	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparaison of results with quebec	Comparison of the results of the French questionnaire, only the questions adapted from the Quebec questionnaire, with the results of the Quebec survey conducted by Jean-Nicolas Boursiquot in 2018.	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): January 2, 2022
• Study Completion (Actual): January 2, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Angioedema; Angioedemas, Hereditary
• Other Study ID Numbers: 38RC21.054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No