NCT01568879

Brief Summary

The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based chronic disease management program compared to patients receiving usual care in achieving a target serum uric acid level in patients with recurrent gout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 28, 2012

Last Update Submit

March 4, 2015

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.

Gout Chronic Disease Management Program

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
  • Gout, unspecified
  • Gout with other specified manifestations
  • Tophaceous gout of ear (274.81) or other sites
  • Gouty nephropathy
  • At least 2 years of continuous Kaiser Foundation Hospital Plan membership
  • Baseline uric acid level above 7.0mg/dl

You may not qualify if:

  • Current cancer diagnosis with active treatment
  • End stage renal disease
  • Pregnant or lactating
  • Patients with a diagnosis of dementia
  • Terminally ill patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California Medical Facilities

All KPNC Facilities, California, United States

Location

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 DiseasesNutritional and Metabolic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Goldfien, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

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 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)