Cost of Care for Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Cost of Care for Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469897
• Other study ID #: CCF 11-291
• Status: Completed
• Phase: N/A
• First received: November 3, 2011
• Last updated: January 12, 2018
• Start date: January 2012
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: March 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
United States	Dell Childrens Medical Center of Central Texas	Austin	Texas
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Children's Hospital & Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct and indirect costs	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.	6 months prior to enrollment
Secondary	Health related quality of life questionnaires	Self reported questionnaires will be completed by parent.	Day 1