Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01568879|
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent or Tophaceous Gout||Other: Control Other: Gout Disease Management Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Effectiveness of a Chronic Disease Management Program for Gout|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
|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||
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568879
|United States, California|
|Kaiser Permanente Northern California Medical Facilities|
|All KPNC Facilities, California, United States|
|Principal Investigator:||Robert Goldfien, MD||Kaiser Permanente|