NCT01469897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

November 3, 2011

Last Update Submit

January 12, 2018

Conditions

Keywords

JIAJuvenile Idiopathic ArthritisCost of CareQuality of LifeQOL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Health related quality of life questionnaires

    Day 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children, adolescents, and young adults with JIA within Cleveland Clinic Health System and at several other participating study sites.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dell Childrens Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andrew Zeft, MD

    Cleveland Clinic Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Pediatric Rheumatology

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 10, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations