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CLinical Prediction Rule Score in Veterans

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Department of Veterans Affairs
Takeda Global Research & Development Center, Inc.
Novartis
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
jasvinder singh, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01418781
First received: August 15, 2011
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition
Gout

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs

Resource links provided by NLM:

MedlinePlus related topics: Gout
U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Health care costs [ Time Frame: Up to 5-year post-survey ] [ Designated as safety issue: No ]
    Total of outpatient, inpatient and emergent care costs


Secondary Outcome Measures:
  • Health utility index, SF-6D [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    at 18-month post-survey

  • Health care utilization [ Time Frame: 1-year post-survey ] [ Designated as safety issue: No ]
    Health care utilization as sum of outpatient, inpatient and emergent care utilization

  • Activity limitation on Katz 6 ADL [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs

  • Mortality [ Time Frame: 5-years ] [ Designated as safety issue: No ]
    Up to 5-year post-survey


Estimated Enrollment: 70000
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gout
Patients with ICD-9 for gout
No Gout
Patients withOUT ICD-9 for gout
Tophaceous gout
Patients with ICD-9 for tophaceous gout
non-tophaceous gout
those with ICD-9 for gout other than the codes specific for tophaceous gout

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

  1. What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?
  2. Does health utility, as calculated by SF-6D, differ in patients with gout compared to patients without gout and between tophaceous and non-tophaceous gout?
  3. What are the relationships between costs and health utility?
  4. How does the burden of illness differ by subgroups of gout patients (costs and utilities)?
  5. What are the VA health care costs for patients with tophaceous gout and are they higher than patients with non-tophaceous gout?

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • participated in the survey
  • Have SF-36 adn utilization data

Exclusion Criteria:

  • Absence of utilization and/or cost data
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418781

Locations
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55123
Sponsors and Collaborators
jasvinder singh
Department of Veterans Affairs
Takeda Global Research & Development Center, Inc.
Novartis
Regeneron Pharmaceuticals
Investigators
Principal Investigator: David Nelson Minneapolis VAMC
  More Information

No publications provided

Responsible Party: jasvinder singh, Worker without compensation, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01418781     History of Changes
Other Study ID Numbers: MVAMC-3669A
Study First Received: August 15, 2011
Last Updated: April 23, 2012
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
gout
cost
utilization

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013