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

Disqualifiers: Trauma, Recent surgery, Critical illness, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people with gout, a type of arthritis that causes painful joint inflammation. The study uses a "storytelling" method (also known as narrative interventions or video narratives) to help participants better understand their condition and manage it, focusing on preventing flare-ups and reducing stigma. Participants will either receive this storytelling intervention or continue with their usual care. Ideal candidates are those diagnosed with gout who can communicate in English. The trial especially focuses on including minority groups in the Southeastern U.S. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in gout management and support.

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 prior data suggests that storytelling is safe for improving gout care?

Research has shown that storytelling methods are safe and easy for people to handle. These methods use engaging and culturally relevant videos featuring patient stories to help individuals better understand and manage gout. The goal is to increase knowledge about gout and encourage adherence to treatment plans.

Studies have not reported any negative effects from storytelling methods, indicating safety for participants. This approach emphasizes education and motivation rather than introducing a new medication, which typically involves fewer risks. Overall, storytelling is considered a low-risk way to help manage gout and improve health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the storytelling approach for gout care because it's a fresh and innovative way to enhance patient understanding and management of their condition. Unlike traditional treatments that focus primarily on medication, this method uses culturally adapted stories delivered on a tablet to increase health literacy, reduce stigma, and motivate lifestyle changes like diet and exercise. By making information more relatable and engaging, storytelling aims to empower patients to better manage their gout, potentially leading to fewer flares and improved long-term care.

What evidence suggests that storytelling is effective for improving gout care?

Research has shown that storytelling techniques have been developed to help people better understand gout and encourage adherence to medication and lifestyle changes. In this trial, some participants will receive a storytelling intervention aimed at removing obstacles to care and improving health outcomes. However, one study found that storytelling was not more effective than other methods in improving gout outcomes for African Americans. Despite this, storytelling seeks to make information more relatable and easier to understand, which might help some people feel more prepared to follow treatment recommendations. Although storytelling hasn't demonstrated a clear advantage yet, it still holds promise for helping some individuals manage their condition better. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10313880/

A multi-step approach to develop a “storytelling” ... We developed a direct-to-patient storytelling intervention to mitigate modifiable barriers to gout care and promote outpatient follow-up and medication ...

2. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-021-02135-w

SToRytelling to Improve Disease outcomes in Gout (STRIDE ... A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/00/NCT02741700/Prot_SAP_000.pdf

SToRytelling to Improve DiseasE outcomes in GOut Our objective is to test the effectiveness of a patient-centered, culturally relevant narrative intervention, or. “storytelling,” based on the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37397431/

A multi-step approach to develop a "storytelling" intervention ... We aimed to describe the development of a video "storytelling" intervention to increase gout knowledge and promote adherence to medications and ...

5. researchgate.net researchgate.net/publication/370910186_A_multi-step_approach_to_develop_a_storytelling_intervention_to_improve_patient_gout_knowledge_and_improve_outpatient_follow-up

(PDF) A multi-step approach to develop a “storytelling ... We aimed to describe the development of a video "storytelling" intervention to increase gout knowledge and promote adherence to medications and follow-up care ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8645140/

SToRytelliing to Improve Disease outcomes in Gout ... The study will assess the efficacy of a behavioral intervention to improve ULT adherence in minority populations with gout.

7. withpower.com withpower.com/trial/phase-gout-5-2021-e767d

Storytelling for Gout Care Improvement · Info for Participants 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 ...