Recurrent or Tophaceous GoutNCT01568879
Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
A study testing Gout Disease Management Program in people with Recurrent or Tophaceous Gout, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Recurrent or Tophaceous Gout
- What is being tested?
- Gout Disease Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current cancer diagnosis with active treatment
- End stage renal disease
- Pregnant or lactating
- Patients with a diagnosis of dementia
- Terminally ill patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California Medical Facilities
All KPNC Facilities, California
About this study
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.
Read the 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.
- Conditions
- Recurrent or Tophaceous Gout
- Being tested
- Control, Gout Disease Management Program
- Keywords
- Recurrent gout, Tophaceous gout, Gout flares, Arthritis, Joint Diseases, Rheumatic Diseases
- Medical subject headings
- Recurrence, Gout, Arthritis, Joint Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Gout Chronic Disease Management Program | Experimental | Not described Receives: Other: Gout Disease Management Program |
| Usual Care | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 6 months follow up
Secondary outcomes (3)
Serum Creatinine
Change in Serum Creatinine
Measured: 0, 12, and 26 weeks
Serum Alanine Aminotransferase (ALT)
Change in serum ALT (a measure of potential toxicity)
Measured: 0, 12, and 26 weeks
Gout flares
Number of gout flares
Measured: 0, 12, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Tophaceous GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Goldfien, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568879
- Sponsor's protocol ID
- CN-11RGold-02-H
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Chronic Disease Management Program for Gout
- ClinicalTrials.gov ID
- NCT01568879
- Acronym / sponsor ID
- CN-11RGold-02-H
- Conditions
- Recurrent or Tophaceous Gout
- Keywords
- Recurrent gout, Tophaceous gout, Gout flares, Arthritis, Joint Diseases, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gout Chronic Disease Management Program | Experimental | Other: Gout Disease Management Program |
| Usual Care | Active comparator | Other: Control |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Current cancer diagnosis with active treatment
- End stage renal disease
- Pregnant or lactating
- Patients with a diagnosis of dementia
- Terminally ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThe 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 | Usual Care |
| Gout Disease Management ProgramThe 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. | Other | Gout Chronic Disease Management Program |
Primary outcome
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.
3 secondary outcomes
Serum Creatinine
Time frame: 0, 12, and 26 weeks
Serum Alanine Aminotransferase (ALT)
Time frame: 0, 12, and 26 weeks
Gout flares
Time frame: 0, 12, and 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Goldfien, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gout Disease Management Program in people with Recurrent or Tophaceous Gout, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Uric Acid Level (time frame: change from baseline at 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.