CLinical Prediction Rule Score in Veterans | NCT01418781

Studies
CLinical Prediction Rule Score in Veterans

NCT01418781

Sponsor

jasvinder singh

Status

Withdrawn

Last Update Posted

Mar 13, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Gout

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding withdrawn by the funding agency; study could not be performed.

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 15, 2011

First Submission Date that Met QC Criteria

Aug 16, 2011

First Posted Date

Aug 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2024

Last Update Posted Date

Mar 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

jasvinder singh, Worker without compensation, Minneapolis Veterans Affairs Medical CenterSponsor-Investigator

Lead Sponsor

jasvinder singhFED

Collaborators

Name	Class
Birmingham, Alabama VA Medical Center	FED
Takeda	INDUSTRY
Novartis	INDUSTRY
Regeneron Pharmaceuticals

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

What are the VA health care costs (inpatient and outpatient) for patients with gout compared to those without gout?
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?
What are the relationships between costs and health utility?
How does the burden of illness differ by subgroups of gout patients (costs and utilities)?
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health care costs	Total of outpatient, inpatient and emergent care costs	Up to 5-year post-survey

Secondary Outcomes

Measure	Description	Time Frame
Health utility index, SF-6D	at 18-month post-survey	18-months
Health care utilization	Health care utilization as sum of outpatient, inpatient and emergent care utilization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participated in the survey
Have SF-36 adn utilization data

Exclusion Criteria:

Absence of utilization and/or cost data

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Nelson	Minneapolis VAMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Minneapolis VA Medical Center		Minneapolis	Minnesota	55123	United States

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout
D010342	Patient Acceptance of Health Care

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided