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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32203
Enrollment
15
Registered
2008-12-16
Start date
2009-01-05
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Lupus SLE Systemic Lupus Erythemasosus

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Fase II: Validity, internal consistency and reliability of SMILEY, translated into dutch. Fase III: Response of the SMILEY, translated into dutch, in changes in disease activity.

Secondary

MeasureTime frame
-

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)