Juvenile Idiopathic ArthritisNCT01469897
Cost of Care for Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by The Cleveland Clinic at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 165 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children, adolescents, and young adults with JIA within Cleveland Clinic Health System and at several other participating study sites.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dell Childrens Medical Center of Central Texas
Austin, Texas, 78723
The Cleveland Clinic
Cleveland, Ohio, 44195
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
About this study
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA, Juvenile Idiopathic Arthritis, Cost of Care, Quality of Life, QOL
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months prior to enrollment
Secondary outcomes (1)
Health related quality of life questionnaires
Self reported questionnaires will be completed by parent.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Zeft, The Cleveland Clinic
- Investigators
- Andrew Zeft, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469897
- Sponsor's protocol ID
- CCF 11-291
- Status last verified
- Jan 2018
- First submitted
- 3 Nov 2011
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Care for Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01469897
- Acronym / sponsor ID
- CCF 11-291
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA, Juvenile Idiopathic Arthritis, Cost of Care, Quality of Life, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, adolescents, and young adults with JIA within Cleveland Clinic Health System and at several other participating study sites.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Health related quality of life questionnaires
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Zeft, MD principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by The Cleveland Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct and indirect costs (time frame: 6 months prior to enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.