Health-related Quality of Life Measure in Pediatric Lupus
Public ClinicalTrials.gov record NCT00280137. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00280137
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 2 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2004
- Primary completion
- Oct 31, 2012
- Completion
- Nov 30, 2013
- Last update posted
- Apr 10, 2016
2004 – 2013
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | — | — |
| La Rabida Children's Hospital - The University of Chicago | Chicago | Illinois | 60615 | — |
| New England Medical Center -Tufts | Boston | Massachusetts | — | — |
| University of Mississippi Medical Center | Jackson | Mississippi | — | — |
| Hackensack University Medical Center | Hackensack | New Jersey | — | — |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| University of Medicine and Dentistry - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| The CLeveland CLinic | Cleveland | Ohio | — | — |
| University Hospital Case Medical Center | Cleveland | Ohio | — | — |
| Legacy Health System | Portland | Oregon | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00280137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 10, 2016 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00280137 live on ClinicalTrials.gov.