NCT01418781

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

August 15, 2011

Last Update Submit

March 11, 2024

Conditions

Gout

Keywords

goutcostutilization

Outcome Measures

Primary Outcomes (1)

  • Health care costs

    Total of outpatient, inpatient and emergent care costs

    Up to 5-year post-survey

Secondary Outcomes (4)

  • Health utility index, SF-6D

    18-months

  • Health care utilization

    1-year post-survey

  • Activity limitation on Katz 6 ADL

    18-months

  • Mortality

    5-years

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Absence of utilization and/or cost data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55123, United States

Location

MeSH Terms

Conditions

GoutPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • David Nelson

    Minneapolis VAMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Worker without compensation

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 17, 2011

Study Start

January 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

US(1)