Gout in the ED and Improving Research Participation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Gout diagnosis meeting 2015 American College of Rheumatology and European League Against Rheumatism classification criteria,99,140.
  • - Adult > 18 years of age, 3) Able to communicate and understand English language (a future objective, with additional resources, will include Spanish translation of all study materials).
Key

exclusion criteria:

  • - History of specialty care visit for gout (e.g. rheumatology) in the past 2 years.
  • - Life expectancy of < 6 months.
  • - Past use of pegloticase (as a marker of past extensive gout care) - Current critical illness leading to admission to high acuity medical care unit (ICU, stepdown unit) or requiring surgical intervention (general anesthesia) in the 2 weeks after ED visit.
  • - Concomitant rheumatic disease including infectious arthritis, rheumatoid arthritis, or seronegative spondyloarthropathy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04075903
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gout
Additional Details

Gout is a chronic disease that affects over 9 million Americans. It is characterized by intermittent flares associated with severe pain. The prevalence of gout has been steadily increasing over several decades and it correlates with the rising burden of obesity, chronic cardiac and renal disease, all conditions overrepresented in the Southeastern U.S.

  • - particularly in African Americans.
In addition, many gout patients are not adherent with their follow-up visits due to a lack of awareness of the consequences of untreated gout and/or poor access to health care. As a result, US emergency departments (EDs) are delivering an increasing amount of gout care for underserved populations. To address this significant public health problems teams at Vanderbilt University Medical Center (VUMC) and the University of Alabama at Birmingham (UAB) are collaborating on a novel emergency department-led intervention aimed at improving the gout care patients receive, during periods of acute flare and long-term. Investigators hypothesize that the use of educational material including cultural appropriate stories about what it is like to live with gout and the use of navigators who will help patients better coordinate their care, will be associated with improved rates of patients that have a follow-up visit addressing gout after the ED visit. A secondary goal is to enhance participation of underrepresented minorities in biomedical research in the Deep South as part of an NIH funded gout center at UAB. Investigators will recruit and enroll 280 adults (at least 18 years of age) that have confirmed gout. Participants will include men and women of all races/ethnicities. Recruitment will occur in the EDs at UAB and VUMC. Qualifying patients will be assigned by chance to get either 1) our enhanced educational materials coupled (at UAB) with a lay person who can help them coordinate their care or 2) to receive the current usual standard of care for their gout. After a gout diagnosis is confirmed by a research assistant, informed consent will be obtained. Following enrollment, participants will complete questionnaires at 3 and 6 months. Beyond follow-up visits, Investigators will also measure differences in the groups between the use of medication for gout treatment, other healthcare visits, changes in weight, satisfaction, and overall health during study follow-up. Leveraging the resources of UAB, including the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funded Center of Research Translation (CORT) in gout and hyperuricemia and ongoing collaborations between these two medical schools, Investigators have assembled a multidisciplinary scientific team, uniquely prepared to execute the proposed study to help medically underserved gout patients and enhance research diversity in the Southeast.

Arms & Interventions

Arms

Experimental: 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).

No Intervention: Control

Usual Care

Interventions

Behavioral: - 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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Jeff Foster, MPH

[email protected]

205-996-6086