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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Hospital for Special Surgery, New York St. Barnabas Medical Center University Hospital Case Medical Center La Rabida Children's Hospital Children's Hospital Los Angeles The Cleveland Clinic |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00280137 |
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:
Condition |
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Systemic Lupus Erythematosus Quality of Life |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Health-Related Quality of Life Measure in Pediatric Lupus |
Estimated Enrollment: | 100 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | April 2012 |
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©. The new 31-item SMILEY© has 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.
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.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The population will consist of outpatients during clinics visits and inpatients during hospitalizations.
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria J Baratelli, BA | 732-235-6555 | baratemj@umdnj.edu |
Contact: Lakshmi N Moorthy, MD, MS | 732-235-4980 | moorthln@umdnj.edu |
United States, California | |
Children's Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Maria J. Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
United States, Illinois | |
La Rabida Children's Hospital | Recruiting |
Chicago, Illinois, United States, 60615 | |
Contact: Maria J Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
United States, New Jersey | |
University of Medicine and Dentistry - Robert Wood Johnson University Hospital | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Maria J Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
Contact: Lakshmi N Moorthy, MD, MS 732-235-4980 moorthln@umdnj.edu | |
Principal Investigator: Lakshmi N Moorthy, MD | |
St. Barnabas Medical Center | Recruiting |
Livingston, New Jersey, United States, 07039 | |
Contact: Maria J Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
United States, New York | |
Hospital for Special Surgery | Recruiting |
New York, New York, United States, 10021 | |
Contact: Lakshmi N Moorthy, MD, MS 732-235-4980 moorthln@umdnj.edu | |
Contact: Maria J Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Maria J. Baratelli, BA 732-235-6555 baratemj@umdnj.edu | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Maria J. Baratelli, BA 732-235-6555 baratemj@umdnj.edu |
Principal Investigator: | Lakshmi N Moorthy, MD, MS | UMDNJ/RWJUH Department of Pediatrics |
Responsible Party: | University of Medicine and Dentistry of New Jersey (UMDNJ) ( L. Nandini Moorthy, MD MS / Chief, Pediatric Rheumatology/ Assistant Professor of Pediatrics ) |
Study ID Numbers: | 4879 |
Study First Received: | January 13, 2006 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00280137 |
Health Authority: | United States: Institutional Review Board |
Quality of Life Pediatric Systemic Lupus Erythematosus |
Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Quality of Life |
Immune System Diseases |