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临床试验/NCT01469897
NCT01469897已完成不适用

Cost of Care for Juvenile Idiopathic Arthritis

The Cleveland Clinic3 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
3
主要终点
Direct and indirect costs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Direct and indirect costs

时间窗: 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.

次要结局

  • Health related quality of life questionnaires(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Zeft

Director, Center for Pediatric Rheumatology

The Cleveland Clinic

研究点 (3)

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