CLinical Prediction Rule Score in Veterans

Gout Clinical Trial

Official title:

Development of CLinical Prediction Rule Score in Veterans: A Study of Impact of Gout on Health Care Utilization and Costs

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01418781
• Other study ID #: MVAMC-3669A
• Status: Withdrawn
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2024
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• participated in the survey

• Have SF-36 adn utilization data

Exclusion Criteria:

• Absence of utilization and/or cost data

Related Conditions & MeSH terms

• Gout

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
jasvinder singh	Birmingham, Alabama VA Medical Center, Novartis, Regeneron Pharmaceuticals, Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health care costs	Total of outpatient, inpatient and emergent care costs	Up to 5-year post-survey
Secondary	Health utility index, SF-6D	at 18-month post-survey	18-months
Secondary	Health care utilization	Health care utilization as sum of outpatient, inpatient and emergent care utilization	1-year post-survey
Secondary	Activity limitation on Katz 6 ADL	Katz 6 ADL questions assess difficulty with doing 6 key activities, bathing, eating, toileting, walking, getting up and climbing stairs	18-months
Secondary	Mortality	Up to 5-year post-survey	5-years