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CLinical Prediction Rule Score in Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01418781
Recruitment Status : Withdrawn (Funding withdrawn by the funding agency; study could not be performed.)
First Posted : August 17, 2011
Last Update Posted : March 16, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
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


Study Design

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : January 2008
Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Health care costs [ Time Frame: Up to 5-year post-survey ]
    Total of outpatient, inpatient and emergent care costs


Secondary Outcome Measures :
  1. Health utility index, SF-6D [ Time Frame: 18-months ]
    at 18-month post-survey

  2. Health care utilization [ Time Frame: 1-year post-survey ]
    Health care utilization as sum of outpatient, inpatient and emergent care utilization

  3. Activity limitation on Katz 6 ADL [ Time Frame: 18-months ]
    Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs

  4. Mortality [ Time Frame: 5-years ]
    Up to 5-year post-survey


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418781


Locations
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55123
Sponsors and Collaborators
jasvinder singh
VA Office of Research and Development
Takeda
Novartis
Regeneron Pharmaceuticals
Investigators
Principal Investigator: David Nelson Minneapolis VAMC
More Information

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
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

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