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OpenTrials
Completed

NCT Number: NCT01469897

Cost of Care for Juvenile Idiopathic Arthritis

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital & Medical Center, Omaha, Nebraska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Health related quality of life questionnaires

    Time frame: Day 1

    Self reported questionnaires will be completed by parent.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Nov 10, 2011
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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