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GoutNCT02790463

Virtual Gout Clinic

A study testing Pharmacist-Led Intervention in people with Gout, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout care, and implement and evaluate such a strategy in a large, population-based healthcare… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
Pharmacist-Led Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,463 participants
Where
2 sitesUnited States
Study dates
Jan 2013to Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least one prior International Classification of Disease (ICD) 9 code for gout (274.xx)
  • Received a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

Who cannot join

  • No prior ICD9 code for gout (274.xx)
  • Did not receive a new prescription for allopurinol, defined as no prior allopurinol prescription in the preceding 12 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Kaiser Permanente

    Pasadena, California, 91101

Other trials in United States

About this study

Official title: A Novel Centralized 'Virtual' Gout Clinic for Chronic Gout Management (NIAMS :CoRT)

The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout care, and implement and evaluate such a strategy in a large, population-based healthcare setting. With the use of novel but readily-accessible technology, the investigators will examine the use of a novel, large-scale, and relatively low-cost pharmacy-based intervention, with the goal of optimizing urate lower therapy (ULT) in chronic gout treatment.

Read the detailed description

Gout is a chronic and progressive form of arthritis occurring as a result of monosodium urate deposition in the joints and surrounding tissues. Despite its extremely well known pathogenesis and the availability of highly efficacious therapies, gout continues to lead to considerable morbidity and mortality due to poor management and limited therapeutic adherence. The investigators translational research study will address this deficit in evidence implementation.

The treatment of chronic gout is based primarily on the use of urate lower therapy (ULT) to reduce the frequency of, and eventually eliminate, acute flares in addition to reducing the risk of progressive joint destruction. There are currently four ULT agents approved for the treatment of gout in the United States (US) including probenecid (a uricosuric), pegloticase (a biologic therapy approved for treatment-refractory gout), allopurinol, and febuxostat. Available for more than 40 years, allopurinol remains the most frequently prescribed ULT, accounting for ~99% of all ULT prescriptions. Many early studies confirmed the robust urate lowering effect of allopurinol, a treatment also yielding ample improvements in long-term outcomes including a reduction in gouty flares. A recent 28-week randomized trial examining fixed dose daily allopurinol revealed a 34% reduction in serum urate concentrations vs. a decrease of 3-4% for those receiving placebo. There are factors that contribute to sub-optimal allopurinol administration and likely include, but are not limited to: 1) failure of prescribers to appropriately titrate allopurinol dose to achieve optimal serum urate target levels; 2) poor long term patient adherence to therapy; 3) drug intolerance, recognizing that this affects only a small proportion of patients; 4) limited data regarding the effectiveness of doses exceeding 300 mg/day; and 5) concerns regarding increased toxicity with higher doses, particularly in the context of chronic kidney disease (CKD).

To date, there have been no published studies examining the impact of a large scale intervention implemented to optimize allopurinol administration in gout. Intervention studies that have been done have universally involved small sample sizes and have been limited to single centers, substantially limiting the external validity of these efforts. The impact of these interventions, largely employing prescription audits and performance feedback to providers, have either gone unreported or have been quite modest in effect. Given the potential cost-effectiveness of allopurinol in gout treatment compared to alternative ULTs and the growing number of reports that have consistently characterized its everyday use as sub-optimal, interventions focused on improving and optimizing allopurinol administration in the context of 'real-life' gout care are urgently needed.

Conditions
Gout
Being tested
Pharmacist-Led Intervention
Keywords
Allopurinol
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist-Led InterventionBehavioural

    Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact

Study groups in NCT02790463
Study groupRoleWhat they receive
Usual CareNo interventionParticipants recruited in this arm will receive their usual care for gout as they normally would
InterventionActive comparatorParticipants recruited to this arm will receive their usual gout care + pharmacist-led intervention
Receives: Behavioral: Pharmacist-Led Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sUA < 6.0 mg/dl at 1 Year

    Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year

    Measured: 12 months

  2. Adherence to Medication

    Adherence to prescribed medication

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2018
  4. Study completionOct 2018

Resources

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
1,463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02790463
Sponsor's protocol ID
X121119002
Status last verified
Oct 2019
First submitted
31 May 2016
Last updated
12 Nov 2019
Data monitoring committee
No
Individual data sharing
No: No, not permitted by data use agreements

Publications

  • Mikuls TR, Cheetham TC, Levy GD, Rashid N, Kerimian A, Low KJ, Coburn BW, Redden DT, Saag KG, Foster PJ, Chen L, Curtis JR. Adherence and Outcomes with Urate-Lowering Therapy: A Site-Randomized Trial. Am J Med. 2019 Mar;132(3):354-361. doi: 10.1016/j.amjmed.2018.11.011. Epub 2018 Nov 29.

    PubMed 30503879

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist-Led Intervention in people with Gout, run by University of Alabama at Birmingham at 2 sites 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 2 inclusion and 2 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

sUA < 6.0 mg/dl at 1 Year (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02790463, which also lists 1 linked publication.

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 12 Nov 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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