Gout in the ED and Improving Research Participation
Improving Care for Gout in the Southeast Enhancing Gout Minority Patients Care and Participation in Gout Clinical Research
2 other identifiers
interventional
200
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedResults Posted
Study results publicly available
December 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedMay 7, 2026
November 1, 2025
3.3 years
August 29, 2019
October 1, 2025
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Outpatient Primary Care or Specialist Visits for Gout Treatment
Proportion of participants who attend a primary care or specialist visits for gout treatment
3 months
Study Arms (2)
Intervention
EXPERIMENTALStorytelling 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).
Control
NO INTERVENTIONUsual Care
Interventions
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).
Eligibility Criteria
You may qualify if:
- Gout diagnosis meeting 2015 American College of Rheumatology and European League Against Rheumatism classification criteria,99,140
- Adult \> 18 years of age
- Able to communicate and understand English language (a future objective, with additional resources, will include Spanish translation of all study materials).
You may not qualify if:
- Joint complaint related to significant trauma or recent surgery (\<1 month)
- Life expectancy of \< 6 months
- Current critical illness leading to admission to high acuity medical care unit (ICU, stepdown unit) or requiring surgical intervention (general anesthesia); confirmed septic arthritis or joint infectious arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MetroHealth Medical Centercollaborator
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)collaborator
- University of Iowacollaborator
- University of Alabama at Birminghamlead
- Massachusetts General Hospitalcollaborator
Study Sites (4)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lesley Jackson, MD, MSPH
- Organization
- University of Alabama at Birmingham Division of Clinical Immunology and Rheumatology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 29, 2019
First Posted
September 3, 2019
Study Start
June 1, 2021
Primary Completion
September 20, 2024
Study Completion (Estimated)
July 1, 2026
Last Updated
May 7, 2026
Results First Posted
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
We are prepared to share data in the following ways: (a) perform a final data edit on the complete data set; (b) create a final data file; (c) perform statistical analyses that support the study findings; (c) issue final reports to the appropriate authorities and collaborators; and (e) provide copies of the finalized data sets. The finalized datasets will be made public with the requisite documentation. All datasets made public will be distributed first to all collaborating co-investigators for verification and testing. The mode of dissemination of these public datasets will be via archive files accessible in the public domain. Public datasets will be de-identified so that they are free of all identifiers that would permit linkages to individual research participants and of variables that could lead to deductive disclosure of the identity of individual participants. Bio-specimens collected and stored as part of this study will be made available through requests to the INSIGHT CORT.