Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280137
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2006-01-13
Brief Title:
Health-related Quality of Life Measure in Pediatric Lupus
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Health-related Quality of Life Measure in Pediatric Lupus
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 childrenparents feel about havingtheir 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None