Clinical trial NCT01469897: Cost of Care for Juvenile Idiopathic Arthritis
Official title: Cost of Care for Juvenile Idiopathic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
Juvenile Idiopathic Arthritis
Cost of Care
Quality of Life
QOL
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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 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.

Primary outcomes:
measure: Direct and indirect costs
timeFrame: 6 months prior to enrollment
Secondary outcomes:
measure: Health related quality of life questionnaires
timeFrame: Day 1
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: Dell Childrens Medical Center of Central Texas
state: Texas
Study officials:
affiliation: Cleveland Clinic Children's Hospital
name: Andrew Zeft, MD
role: PRINCIPAL_INVESTIGATOR
References: