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

NCT04888650 | Completed DMC

• 1 other identifier: 38RC21.054
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Hereditary Angioedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparaison of results with quebec

  baseline

Study Arms (1)

angiodema hereditary patients

Patient with HAE with or without C1 inhibitor deficiency will respond to an electronic questionnaire

Other: questionnaire

Interventions

questionnaire OTHER

electronic questionnaire

angiodema hereditary patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with HAE with or without C1 inhibitor deficiency

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, France

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 17, 2021
• Study Start: May 3, 2021
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: May 10, 2023

Record last verified: 2021-04

Locations

FR (1)