NCT00280137

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. 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. 2.to determine responsiveness of SMILEY©
  3. 3.to examine level of agreement between child- and parent-reports of SMILEY© in children with SLE
  4. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

8.4 years

First QC Date

January 13, 2006

Last Update Submit

April 8, 2016

Conditions

Systemic Lupus ErythematosusQuality of Life

Keywords

Quality of LifePediatric Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life - scores of the SMILEY scale for child and parent reports

    At different points of the study

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population will consist of outpatients during clinics visits and inpatients during hospitalizations.

You may qualify if:

  • (1) Willing to participate
  • (2) Have a child with SLE that meets eligibility criteria for the study

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Childrens Hospital Los Angeles

Los Angeles, California, United States

Location

La Rabida Children's Hospital - The University of Chicago

Chicago, Illinois, 60615, United States

Location

New England Medical Center -Tufts

Boston, Massachusetts, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

University of Medicine and Dentistry - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

The CLeveland CLinic

Cleveland, Ohio, United States

Location

University Hospital Case Medical Center

Cleveland, Ohio, United States

Location

Legacy Health System

Portland, Oregon, United States

Location

Related Publications (6)

  • 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. doi: 10.1191/0961203304lu1003oa.

    PMID: 15176658BACKGROUND

  • 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. doi: 10.1002/art.1780350606.

    PMID: 1599520BACKGROUND

  • 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.

    PMID: 9034988BACKGROUND

  • 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. doi: 10.1097/00005650-200108000-00006.

    PMID: 11468499BACKGROUND

  • 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. doi: 10.1097/00005650-199902000-00003.

    PMID: 10024117BACKGROUND

  • 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. doi: 10.1002/art.1780371209.

    PMID: 7986222BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Lakshmi N Moorthy, MD, MS

    UMDNJ/RWJUH Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 20, 2006

Study Start

June 1, 2004

Primary Completion

November 1, 2012

Study Completion

December 1, 2013

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

US(11)