Health-related Quality of Life Measure in Pediatric Lupus
NCT ID: NCT00280137
Last Updated: 2016-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
31 participants
OBSERVATIONAL
2004-06-30
2013-12-31
Brief Summary
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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
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Detailed Description
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During their visit, information about their lupus will be collected from the children and parents, and they will be asked to complete the SMILEY© and questionnaires measuring quality of life, physical function, self-esteem and behavior. They will be given an additional copy of SMILEY©, which they will be asked to complete within 10 days of their initial evaluation and return by mail (self-addressed, stamped envelope will be provided). Then both children and legal guardians will again be asked to complete questionnaires including SMILEY© during their subsequent visits at least every 3-6 month intervals or earlier if there has been a change in disease activity as determined by the physician. Medication use, disease activity and disease severity assessments will be made by the physician with initial and subsequent evaluations. We will determine the psychometrics properties of SMILEY and responsiveness to change in disease activity.
Both national and international sites will be included in the study. SMILEY in addition will be translated and adapated to different languages and subsequently validated. This study will provide valuable information about the impact of lupus on their overall well-being. Being a brief, valid, reliable and easy to administer instrument, SMILEY© would be suitable for use across different age groups, languages and cultures. SMILEY© will be used as an important clinical outcome tool in both clinical and research arenas, thus enabling us to formulate appropriate interventions.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* (2) Have a child with SLE that meets eligibility criteria for the study
Exclusion Criteria
* (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
2 Years
18 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
St. Barnabas Medical Center
OTHER
Hackensack Meridian Health
OTHER
University of Chicago
OTHER
The Cleveland Clinic
OTHER
Children's Hospital Los Angeles
OTHER
Legacy Health System
OTHER
University Hospitals Cleveland Medical Center
OTHER
Tufts Medical Center
OTHER
University of Mississippi Medical Center
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Lakshmi N Moorthy, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UMDNJ/RWJUH Department of Pediatrics
Locations
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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
Countries
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References
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Moorthy LN, Robbins L, Harrison MJ, Peterson MG, Cox N, Onel KB, Lehman TJ. Quality of life in paediatric lupus. Lupus. 2004;13(4):234-40. doi: 10.1191/0961203304lu1003oa.
Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
Stoll T, Stucki G, Malik J, Pyke S, Isenberg DA. Association of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index with measures of disease activity and health status in patients with systemic lupus erythematosus. J Rheumatol. 1997 Feb;24(2):309-13.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
Singh G, Athreya BH, Fries JF, Goldsmith DP. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 1994 Dec;37(12):1761-9. doi: 10.1002/art.1780371209.
Other Identifiers
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0220044879
Identifier Type: -
Identifier Source: org_study_id
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