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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00280137
Other study ID # 0220044879
Secondary ID
Status Completed
Phase N/A
First received January 13, 2006
Last updated April 8, 2016
Start date June 2004
Est. completion date December 2013

Study information

Verified date April 2016
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


Description:

Pediatric lupus is a chronic multisystem rheumatic disease, associated with significant medical and psychosocial implications. Frequent physician visits for routine, urgent or emergent care, limitation of activities, medication side effects, change in body image, fear of the future, and missing school are all disruptive to the patients and parents and impact all spheres of their lives. There is no lupus-specific questionnaire designed to measure the well-being of children with this disease. We developed a brief questionnaire, "Simple Measure of Impact of Lupus Erythematosus in Youngsters© (SMILEY©) with both child and parent versions. We conducted further research about how children/parents feel about having/their children having lupus and used those responses to modify the preliminary SMILEY©. After several iterations, the SMILEY with 26 questions was developed with parallel child- and parent-versions with responses in the form of 5 faces-scale denoting different expressions, in order to ensure easy comprehension across different ages and cultures.

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- (1) Willing to participate

- (2) Have a child with SLE that meets eligibility criteria for the study

Exclusion Criteria:

- (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

Study Design

Time Perspective: Prospective


Locations

Country Name City State
United States New England Medical Center -Tufts Boston Massachusetts
United States La Rabida Children's Hospital - The University of Chicago Chicago Illinois
United States The CLeveland CLinic Cleveland Ohio
United States University Hospital Case Medical Center Cleveland Ohio
United States Hackensack University Medical Center Hackensack New Jersey
United States University of Mississippi Medical Center Jackson Mississippi
United States St. Barnabas Medical Center Livingston New Jersey
United States Childrens Hospital Los Angeles Los Angeles California
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 Legacy Health System Portland Oregon

Sponsors (11)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey Children's Hospital Los Angeles, Hackensack University Medical Center, Hospital for Special Surgery, New York, Legacy Health System, St. Barnabas Medical Center, The Cleveland Clinic, Tufts Medical Center, University Hospital Case Medical Center, University of Chicago, University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Health Related Quality of Life - scores of the SMILEY scale for child and parent reports At different points of the study No
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