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Cost of Care for Juvenile Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT01469897
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Juvenile Idiopathic Arthritis

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.


Study Design

Study Type : Observational
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cost of Care for Juvenile Idiopathic Arthritis
Study Start Date : January 2012
Primary Completion Date : December 2014
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Direct and indirect costs [ Time Frame: 6 months prior to enrollment ]
    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 :
  1. Health related quality of life questionnaires [ Time Frame: Day 1 ]
    Self reported questionnaires will be completed by parent.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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): NCT01469897


Locations
United States, Nebraska
Children's Hospital & Medical Center
Omaha, Nebraska, United States, 68114
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Dell Childrens Medical Center of Central Texas
Austin, Texas, United States, 78723
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Andrew Zeft, MD Cleveland Clinic Children's Hospital
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01469897     History of Changes
Other Study ID Numbers: CCF 11-291
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

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

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