CLinical Prediction Rule Score in Veterans
| Tracking Information | |||||
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| First Received Date ICMJE | August 15, 2011 | ||||
| Last Updated Date | April 23, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Health care costs [ Time Frame: Up to 5-year post-survey ] [ Designated as safety issue: No ] Total of outpatient, inpatient and emergent care costs |
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| Original Primary Outcome Measures ICMJE |
Health care costs [ Time Frame: 1-year post-survey ] [ Designated as safety issue: No ] Total of outpatient, inpatient and emergent care costs |
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| Change History | Complete list of historical versions of study NCT01418781 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CLinical Prediction Rule Score in Veterans | ||||
| Official Title ICMJE | Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs | ||||
| Brief Summary | We will study whether the health care costs and health utilities differ in patients with gout and those without gout and whether they differ between those with more severe versus less severe gout |
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| Detailed Description | The purpose of this project is to study the out-patient and inpatient utilization and costs associated with tophaceous gout (a classic form of treatment-failure gout), compare these costs to patients with non-tophaceous gout and evaluate health utilities associated with these gout states. The analyses will be conducted in a manner to support a burden of illness type of presentation / manuscript. Study Questions
Inclusion criteria Patients with and without gout from the Veterans database described above will be included in the analyses for Study aims 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with and without gout from the Veterans Upper Midwest SF-36 survey database will be included in the analyses for Study questions 1 and 5. This is approximately 3000 gout patients and 67,000 non-gout patients Patients with SF-36 data from the above cohort will be included in the analyses for Study aims 2-4. This is approximately 1500 gout patients and 38,000 non-gout patients |
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| Condition ICMJE | Gout | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 70000 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01418781 | ||||
| Other Study ID Numbers ICMJE | MVAMC-3669A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | jasvinder singh, Minneapolis Veterans Affairs Medical Center | ||||
| Study Sponsor ICMJE | jasvinder singh | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Minneapolis Veterans Affairs Medical Center | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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