Cost of Care for Juvenile Idiopathic Arthritis

NCT ID: NCT01469897

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andrew Zeft

Director, Center for Pediatric Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Zeft, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Children's Hospital

Locations

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Children's Hospital & Medical Center

Omaha, Nebraska, United States

Site Status

The Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Dell Childrens Medical Center of Central Texas

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CCF 11-291

Identifier Type: -

Identifier Source: org_study_id

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