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Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

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ClinicalTrials.gov Identifier: NCT01568879
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE April 2, 2012
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
Serum Uric Acid Level [ Time Frame: change from baseline at 6 months follow up ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01568879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2012)
  • Serum Creatinine [ Time Frame: 0, 12, and 26 weeks ]
    Change in Serum Creatinine
  • Serum Alanine Aminotransferase (ALT) [ Time Frame: 0, 12, and 26 weeks ]
    Change in serum ALT (a measure of potential toxicity)
  • Gout flares [ Time Frame: 0, 12, and 26 weeks ]
    Number of gout flares
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
Official Title  ICMJE Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Tophaceous Gout
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Gout Chronic Disease Management Program
    Intervention: Other: Gout Disease Management Program
  • Active Comparator: Usual Care
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2014)
104
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2012)
98
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01568879
Other Study ID Numbers  ICMJE CN-11RGold-02-H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Goldfien, MD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP