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Changes in the Socio-economic Burden of Epidermolysis Bullosa in Europe

Recruiting
Conditions
Q81
Epidermolysis bullosa
Registration Number
DRKS00031426
Lead Sponsor
European Joint Programme Rare Diseases
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
300
Inclusion Criteria

Affected by Epidermolysis bullosa and main care giver

Exclusion Criteria

not affected by Epidermolysis bullosa or not main caregiver

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
An online questionnaire study will be conducted. The start of the distribution of the questionnaire is planned for 9/23 and participants can complete the questionnaire until 5/24.<br><br>Different QoL tests are used depending on age and relation to EB (affected/caregiver). For each age and person group, one generic test (EQ-5D-5L, EQ-5D-Y self-assessment and EQ-5D-Y external assessment) and one disease-specific QoL test are used (QoLEB, CDLQI cartoon version, CDLQI text version and EB-BoD).<br><br>Main caregiver: EQ-5D-5L & EB-BoD<br>- Affected person > 16 years: EQ-5D-5L<br>- Affected person > 11 years: QoLEB<br>- Affected persons 8-10 years: CDLQI<br>- Affected 8-15 years: EQ-5D-Y (if necessary with the help of parents or caregiver)<br>- Affected 4-7 years: EQ-5D-Y (external assessment by caregiver) & CDLQI (cartoon version)
Secondary Outcome Measures
NameTimeMethod
An online questionnaire study will be conducted. The start of the distribution of the questionnaire is planned for 9/23 and participants can complete the questionnaire until 5/24.<br>Besides HRQoL the resource use and the cost of illness will be measured (items were generated by the project consortium):<br>- Use of healthcare and non-healthcare resources<br>- Employment and productivity / Education<br>- Other out-of-pocket expanses<br>- Carer´s employment and productivity
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