| City: |
|
Chicago |
|
State:
|
|
IL |
| Zip Code: |
|
60615 |
| Conditions: |
|
Systemic Lupus Erythematosus - Quality of Life |
| Purpose: |
|
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 (as measured by child- and parent-reports
of the CHAQ).
|
| Study summary: |
|
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. |
| Criteria: |
|
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 is available at: |
|
La Rabida Children's Hospital
Chicago, IL 60615
United States
Primary Contact:
Maria J Baratelli, BA
Email: baratemj@umdnj.edu
Phone: 732-235-6555
Secondary Contact:
Maria J Baratelli, BA
Email: baratemj@umdnj.edu
Phone: 732-235-6555 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 21, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|