Trials Sponsors Conditions Drugs Pricing

Conditions

Recurrent or Tophaceous Gout

Keywords

Recurrent goutTophaceous goutGout flaresArthritisJoint DiseasesRheumatic Diseases

Outcome Measures

Primary Outcomes (1)

Serum Uric Acid Level
attainment and maintenance of a serum uric acid level of 6.0 mg/dl or less. The outcome will be considered positive if that level is attained and the 6 month follow up value remains at the target level.
change from baseline at 6 months follow up

Secondary Outcomes (3)

Serum Creatinine
0, 12, and 26 weeks
Serum Alanine Aminotransferase (ALT)
0, 12, and 26 weeks
Gout flares
0, 12, and 26 weeks

Study Arms (2)

Gout Chronic Disease Management Program

EXPERIMENTAL

Other: Gout Disease Management Program

Usual Care

ACTIVE COMPARATOR

Other: Control

Interventions

ControlOther

The control group will receive care from their primary care physician that reflects the actual current care received by KPNC patients, but will not receive any treatment recommendations from the study protocol. The control subject will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling.

Usual Care

Gout Disease Management ProgramOther

The experimental group will utilize standard guidelines for the initiation of uric acid lowering treatments, and approved medications. The study protocol treatments include medication management, dietary guidelines, and basic educational materials on gout and its management. No non-formulary medications or devices will be used. The experimental procedure to be tested is the use of a structured protocol to manage and monitor standard treatments.

Eligibility Criteria

Age21 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Three or more outpatient/ED visits in a 24-month period prior to selection for study with one of these primary visit diagnoses:
Gouty arthropathy

Sponsors & Collaborators

Kaiser Permanente
Otherlead

Study Sites (1)

Kaiser Permanente Northern California Medical Facilities

All KPNC Facilities, California, United States

MeSH Terms

Conditions

RecurrenceGoutArthritisJoint DiseasesRheumatic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMusculoskeletal DiseasesCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic Diseases

Study Officials

Robert Goldfien, MD
Kaiser Permanente
PRINCIPAL INVESTIGATOR

Enrollment

104 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 2, 2012

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Gout Chronic Disease Management Program

Usual Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Gout Chronic Disease Management Program

Usual Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations