Validation of Quality of Life Questionnaire 'Simple Measure of Impact of Lupus Erythematosus in Youngsters (SMILEY)', MEC-2008-086

Recruiting

• Conditions: Lupus; SLE; 10003816; Systemic Lupus Erythemasosus

• Registration Number: NL-OMON32203
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

For children: 1) Fulfillment of the ACR-criteria for SLE, revised in 1982, 2) Age 2-18 years, 3) Able to participate in the opinion of the pediatric rheumatologist (If the child is too young to understand the child-questionnaires these questionnaires will not be used and only the questionnaires of the parents / legal guardians will be used. The child will be included in the study for its disease characteristics.) and 4) For children < 18 years, one legal guardian willing to sign consent.;For parents/ legal guardians: 1) Having a child with SLE that meets eligibility criteria for the study and 2) Willing to participate.

Exclusion Criteria

1) Not able to speak the language in which the adaptation and validation will be conducted, 2) Subjects not well enough to complete the questionnaires, 3) Physical or mental disabilities which would seriously affect the individual*s ability to understand the informed consent and/ or study questionnaires and 4) Refusal to participate.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fase II: Validity, internal consistency and reliability of SMILEY, translated<br /><br>into dutch.<br /><br>Fase III: Response of the SMILEY, translated into dutch, in changes in disease<br /><br>activity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>