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| ID | Type | Description | Link |
|---|---|---|---|
| P50AR060772 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| MetroHealth Medical Center | OTHER |
| University of Iowa | OTHER |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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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.
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 the University of Alabama at Birmingham (UAB), University of Iowa, Massachusetts General Hospital (MGH), and MetroHealth Medical Center 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 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, University of Iowa, MGH, and MetroHealth. 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 medical institutions, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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). |
|
| Control | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storytelling | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Key exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Iowa Hospitals and Clinics |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Storytelling and Navigation 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, along with post-emergency department visit patient navigation to promote outpatient follow-up |
| FG001 | Control | Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Storytelling and Navigation 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, along with post-emergency department visit patient navigation to promote outpatient follow-up. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Outpatient Primary Care or Specialist Visits for Gout Treatment | Proportion of participants who attend a primary care or specialist visits for gout treatment | Posted | Count of Participants | Participants | 3 months |
|
3 months
This was a minimal risk study. No adverse events or serious adverse events were reported during follow-up outcomes assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Storytelling and Navigation 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, along with post-emergency department visit patient navigation to promote outpatient follow-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesley Jackson, MD, MSPH | University of Alabama at Birmingham Division of Clinical Immunology and Rheumatology | 205-934-1779 | lejackson@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2024 | Sep 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| NIH |
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|
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| BG001 | Control | Usual Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Yearly Income | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Alcohol Use | Count of Participants | Participants |
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Usual Care
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 0 |
| 135 |
| EG001 | Control | Usual Care | 0 | 65 | 0 | 65 | 0 | 65 |
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |