Health-related Quality of Life Measure in Pediatric Lupus

Completed

Conditions studied: Systemic Lupus Erythematosus, Quality of Life

In brief

To examine the psychometric properties of a brief quality of life (QOL) instrument for use in pediatric systemic lupus erythematosus (SLE). The purpose of this prospective study is primarily to determine the validity and reliability of a new health-related quality of life (HRQOL) measure in children with systemic lupus erythematous (SLE). We wish to secondarily examine concordance between child- and parent-reports of the HRQOL measure and identify factors associated with poorer HRQOL in them. Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is no disease-specific instrument for measuring HRQOL in children with SLE. In response to these concerns, we developed the "Simple Measure of Impact of Lupus Erythematosus in Youngsters© (SMILEY©). Establishing the validity and reliability of SMILEY©, examining child-parent agreement and identifying factors associated with poorer HRQOL will enable us to measure the impact of SLE in children, and formulate appropriate interventions for this sensitive population. We plan the following specific aims: 1. to determine construct validity and reliability of SMILEY© child and parent versions in children with SLE using gold standards (Pediatric Quality of Life inventory - PedsQL generic and rheumatology modules, Childhood Health Assessment Questionnaire -CHAQ) 2. to determine responsiveness of SMILEY© 3. to examine level of agreement between child- and parent-reports of SMILEY© in children with SLE 4. to identify medical (steroid use, use of disease modifying agents such as cytoxan, cellcept, thalidomide, or cyclosporine, disease duration, disease activity and disease damage etc.) and psychosocial (self-concept, socioeconomic status) factors that affect HRQOL (as measured by child- and parent-reports of SMILEY© and PedsQL generic and rheumatology modules) and physical function 5) to translate, adapt and validate SMILEY in different languages

Key facts

Study ID

NCT00280137

Run by

Rutgers, The State University of New Jersey

People needed

31

Starts

2004-06-01

Expected to finish

2013-12-01

Last updated by the study team

2016-04-11

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (1) Willing to participate
• (2) Have a child with SLE that meets eligibility criteria for the study

You may not qualify if…

• (1) Subjects who are not well enough to complete the questionnaires
• (2) Physical or mental disabilities which would seriously affect the individual's ability to understand the informed consent or study questionnaires
• (3) Refusal to participate

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• La Rabida Children's Hospital - The University of Chicago — Chicago, Illinois, United States
• New England Medical Center -Tufts — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• St. Barnabas Medical Center — Livingston, New Jersey, United States
• University of Medicine and Dentistry - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Hospital for Special Surgery — New York, New York, United States
• The CLeveland CLinic — Cleveland, Ohio, United States
• University Hospital Case Medical Center — Cleveland, Ohio, United States
• Legacy Health System — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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