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Health-related Quality of Life Measure in Pediatric Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00280137
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : April 11, 2016
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
Systemic Lupus Erythematosus Quality of Life

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 31 participants
Time Perspective: Prospective
Official Title: Health-related Quality of Life Measure in Pediatric Lupus
Study Start Date : June 2004
Primary Completion Date : November 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Health Related Quality of Life - scores of the SMILEY scale for child and parent reports [ Time Frame: At different points of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will consist of outpatients during clinics visits and inpatients during hospitalizations.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280137

United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States
United States, Illinois
La Rabida Children's Hospital - The University of Chicago
Chicago, Illinois, United States, 60615
United States, Massachusetts
New England Medical Center -Tufts
Boston, Massachusetts, United States
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
University of Medicine and Dentistry - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
The CLeveland CLinic
Cleveland, Ohio, United States
University Hospital Case Medical Center
Cleveland, Ohio, United States
United States, Oregon
Legacy Health System
Portland, Oregon, United States
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Hospital for Special Surgery, New York
St. Barnabas Medical Center
Hackensack University Medical Center
University of Chicago
The Cleveland Clinic
Children's Hospital Los Angeles
Legacy Health System
University Hospitals Cleveland Medical Center
Tufts Medical Center
University of Mississippi Medical Center
Principal Investigator: Lakshmi N Moorthy, MD, MS UMDNJ/RWJUH Department of Pediatrics
More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00280137     History of Changes
Other Study ID Numbers: 0220044879
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Rutgers, The State University of New Jersey:
Quality of Life
Pediatric Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases