What side effects are associated with this type of intervention?

Common treatments for gout, such as allopurinol and febuxostat, are generally well-tolerated but can have side effects. Allopurinol may cause skin rashes, gastrointestinal upset, and in rare cases, severe hypersensitivity reactions. Febuxostat has been associated with liver enzyme abnormalities and a potentially higher risk of cardiovascular events, although this risk is not statistically significant. Both medications can lead to gout flares when initiating therapy, so prophylactic anti-inflammatory treatment is often recommended.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gout, including allopurinol, febuxostat, and probenecid. Allopurinol and febuxostat are xanthine oxidase inhibitors that reduce the production of uric acid, while probenecid is a uricosuric agent that increases the excretion of uric acid. These medications are commonly used to manage chronic gout and reduce uric acid levels, which aligns with the goals of the Emergency Department Led Gout Management Protocol aimed at reducing uric acid levels and inflammation.

What other types of research exist?

Promising alternatives for gout management in 2024 include: 1) Combination therapy using xanthine oxidase inhibitors (e.g., allopurinol) with uricosuric agents (e.g., probenecid, lesinurad) for patients not achieving target serum urate levels with monotherapy. 2) Dietary interventions such as the DASH or Mediterranean diets, which have shown potential in lowering serum urate levels. 3) New urate-lowering drugs in development, including advanced uricosurics and recombinant uricases, which may offer improved efficacy and safety profiles.

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Storytelling for Gout Care Improvement

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Concomitant rheumatic disease including infectious arthritis, rheumatoid arthritis, or seronegative spondyloarthropathy.

History of specialty care visit for gout (e.g. rheumatology) in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the care patients with gout receive, both during acute exacerbations and long-term, as well as to enhance participation of minorities in biomedical research in the Deep South.

Who is the study for?

This trial is for adults over 18 with gout who have seen a specialist in the past 2 years and can understand English. It's not for those with less than 6 months to live, recent critical illness or surgery, other rheumatic diseases, or those who've used pegloticase.

What is being tested?

The study tests a new way to improve care for gout patients in emergency departments using storytelling. It also aims to increase research participation among minorities in the Southeastern U.S., particularly African Americans.

What are the potential side effects?

Since this intervention involves storytelling rather than medication, traditional side effects are not expected. However, participants may experience emotional responses related to discussing their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a rheumatic condition like rheumatoid arthritis.

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I have seen a specialist for gout in the last 2 years.

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I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Outpatient primary care or specialist visits for gout treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Storytelling A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing "storytelling" to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, or ii) usual gout care (control state).

Group II: ControlActive Control1 Intervention

Usual Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Storytelling

2021

N/A

~370

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for gout include urate-lowering therapies (ULTs) such as allopurinol and febuxostat, and anti-inflammatory medications like colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs). ULTs work by inhibiting xanthine oxidase, an enzyme involved in the production of uric acid, thereby reducing serum urate levels and preventing the formation of urate crystals in joints. Anti-inflammatory medications help manage acute gout flares by reducing inflammation and pain. These treatments are crucial for gout patients as they address both the underlying cause (high uric acid levels) and the symptoms (inflammation and pain), improving overall disease management and quality of life.

Effects of allopurinol on renal function in patients with diabetes: a systematic review and meta-analysis.Clinical interventions to improve adherence to urate-lowering therapy in patients with gout: a systematic review.Association between hyperuricemia, gout, urate lowering therapy, and osteoarthritis: A protocol for a systematic review and meta-analysis.