Trial record 11 of 114 for:    "Gout"

Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01568879
First received: March 28, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Recurrent or Tophaceous Gout
Other: Control
Other: Gout Disease Management Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Serum Uric Acid Level [ Time Frame: change from baseline at 6 months follow up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Serum Creatinine [ Time Frame: 0, 12, and 26 weeks ] [ Designated as safety issue: No ]
    Change in Serum Creatinine

  • Serum Alanine Aminotransferase (ALT) [ Time Frame: 0, 12, and 26 weeks ] [ Designated as safety issue: No ]
    Change in serum ALT (a measure of potential toxicity)

  • Gout flares [ Time Frame: 0, 12, and 26 weeks ] [ Designated as safety issue: No ]
    Number of gout flares


Enrollment: 104
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gout Chronic Disease Management Program Other: Gout Disease Management Program
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.
Active Comparator: Usual Care Other: Control
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.

Detailed Description:

Gout is a chronic condition with intermittent symptoms and should be managed through an outcome-based disease management approach. Unlike other common chronic conditions, strategies for population management in gout patients have not been tested. The study will identify adult members of Kaiser Permanente (KP) Northern California with a diagnosis of gout and 3 or more outpatient or Emergency Department visits for gout over a 1-year period preceding study enrollment. These patients will be randomized to either an active management group, or to usual care. The participants will be enrolled and followed over a period of 26 weeks. The primary outcome to be measured will be the attainment and maintenance of a uric acid lowering regimen targeted to achieve serum uric acid level of 6.0 mg/dl or less. The treatment protocol will use standard treatment guidelines to lower and maintain uric acid levels to less than or equal to 6.0 mg/dl (or maximum doses of uric acid lowering medications) and provide patient education and dietary counseling. Monitoring and medication management will be carried out by a licensed clinical pharmacist under the supervision of an experienced rheumatologist. Control subjects will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling, but otherwise receive usual care. The demonstration that a chronic disease management approach to gout care can improve the health and reduce morbidity in patients with gout may illuminate a simple path towards improved quality of life and reduced morbidity in this growing population of patients.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current cancer diagnosis with active treatment
  • End stage renal disease
  • Pregnant or lactating
  • Patients with a diagnosis of dementia
  • Terminally ill patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568879

Locations
United States, California
Kaiser Permanente Northern California Medical Facilities
All KPNC Facilities, California, United States
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Robert Goldfien, MD Kaiser Permanente Northern California
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01568879     History of Changes
Other Study ID Numbers: CN-11RGold-02-H
Study First Received: March 28, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Recurrent gout
Tophaceous gout
Gout flares
Arthritis
Joint Diseases
Rheumatic Diseases

Additional relevant MeSH terms:
Gout
Chronic Disease
Disease Attributes
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014