Health-related Quality of Life Measure in Pediatric Lupus

Summary

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

Conditions

• Systemic Lupus Erythematosus
• Quality of Life

Sponsors & Collaborators

• Hospital for Special Surgery, New York

  collaborator OTHER

• St. Barnabas Medical Center

  collaborator OTHER

• Hackensack Meridian Health

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Legacy Health System

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Lakshmi N Moorthy, MD, MS · UMDNJ/RWJUH Department of Pediatrics

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-06-30

Primary Completion

2012-11-30

Completion

2013-12-31

Countries

• United States

Study Locations