Storytelling for Gout Care Improvement

Recruiting at 3 trial locations

Overseen By JEFF FOSTER, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel emergency department led intervention we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Storytelling for Gout Care Improvement?

Research shows that storytelling interventions can improve knowledge, attitudes, and behaviors in managing chronic diseases like gout and diabetes. Specifically, a culturally appropriate storytelling approach has been tested to improve medication adherence and disease outcomes in African American veterans with gout. ^{1 2 3 4 5}

How does the storytelling treatment for gout differ from other treatments?

The storytelling treatment for gout is unique because it uses culturally appropriate stories to improve patients' understanding and management of their condition, focusing on increasing medication adherence and follow-up care. Unlike traditional treatments that primarily involve medication, this approach aims to change behavior and attitudes through engaging narratives, particularly targeting African American veterans with gout. ^{1 2 3 6 7}

Eligibility Criteria

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.

Inclusion Criteria

Gout diagnosis meeting 2015 American College of Rheumatology and European League Against Rheumatism classification criteria,99,140

I have a rheumatic condition like rheumatoid arthritis.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enhanced educational materials with care coordination or usual care for gout

3 months

Initial ED visit, followed by educational sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaires at 3 and 6 months

6 months

Questionnaires at 3 and 6 months

Long-term follow-up

Participants' use of medication, healthcare visits, and overall health are monitored

Long-term

Treatment Details

Interventions

• Storytelling

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A multi-step approach to develop a "storytelling" intervention to improve patient gout knowledge and improve outpatient follow-up. [2023]

2. England pubmed.ncbi.nlm.nih.gov

SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol. [2022]

3. England pubmed.ncbi.nlm.nih.gov

SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Group-based storytelling in disease self-management among people with diabetes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

How patients with gout become engaged in disease management: a constructivist grounded theory study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

How Can We Improve Disease Education in People with Gout? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of healthcare educational and behavioral interventions to improve gout outcomes: a systematic review and meta-analysis. [2022]