Text Size

Cost of Care for Juvenile Idiopathic Arthritis

This study is not yet open for participant recruitment.
Verified November 2011 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Steven Spalding, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01469897
First received: November 3, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

This project seeks to collect data on healthcare utilization and expenditure rates in Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with disease activity and outcome measures and determine methods by which to reduce the economic impact while improving outcomes.


Condition
Juvenile Idiopathic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cost of Care for Juvenile Idiopathic Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Direct and indirect costs [ Time Frame: 6 months prior to enrollment ] [ Designated as safety issue: No ]
    Patient's history will be reviewed for the prior 6 months to enrollment for expenses incurred related to JIA and it's treatment. This will be done through chart review and questionnaires completed by the patient/parent.


Secondary Outcome Measures:
  • Health related quality of life questionnaires [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

SPECIFIC AIMS AND OBJECTIVES

The specific aims of this registry protocol are:

  • To create and maintain a secure online database of patients with JIA
  • To collect data elements related to cost of care in patients with JIA
  • Compare standard outcome and disease activity measures to health care expenditures in JIA
  • To determine methods by which to reduce costs while improving outcomes and quality of care

The study plans to enroll 300 or more subjects from 3 medical centers in the US over a 24 month period. Subjects in the study are patients with Juvenile Idiopathic Arthritis.

Enrollment into the protocol will include key demographic and clinical data including, medication exposures, disease severity, and function including disease-specific data elements; and estimates of health care service utilization and health care expenditures. Data will be collected once per subject within the context of a standard of care visit.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children, adolescents, and young adults with JIA within Cleveland Clinic Health System and at several other participating study sites.

Criteria

Inclusion Criteria:

  • Subject has been diagnosed with JIA by a pediatric rheumatologist according to published criteria.
  • Person providing consent must be able to read English.
  • Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures.

Exclusion Criteria:

  • Subject/ legal guardian is unwilling to provide consent, cannot read English, or does not meet published criteria for JIA.
  • Coexisting rheumatologic disorder
  • Diagnosis of fibromyalgia
  • Participation in a drug trial in the past 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469897

Contacts
Contact: Deborah Latham, BA 1-800-223-2273 ext 54944 lathamd2@ccf.org
Contact: Carolyn Mawhorter, RN 1-800-223-2273 ext 57811 mawhorc@ccf.org

Locations
United States, Nebraska
Children's Hospital & Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68114
Contact: Kym L Abraham, RN, BSN     402-559-2977     kabraham@unmc.edu    
Principal Investigator: Adam L. Reinhardt, M.D.            
United States, Ohio
The Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Deborah Latham, BA     800-223-2273 ext 54944     lathamd2@ccf.org    
United States, Texas
Dell Childrens Medical Center of Central Texas Not yet recruiting
Austin, Texas, United States, 78723
Contact: Collin A Hovinga, PharmD,MS,FCCP     (512) 628-1800     caHovinga@seton.org    
Principal Investigator: Ruy Carrasco, MD            
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Steven Spalding, MD Cleveland Clinic Children's Hospital
  More Information

No publications provided

Responsible Party: Steven Spalding, Director, Center for Pediatric Rheumatology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01469897     History of Changes
Other Study ID Numbers: CCF 11-291
Study First Received: November 3, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
JIA
Juvenile Idiopathic Arthritis
Cost of Care
Quality of Life
QOL

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013