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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MD019235 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated COVID-19 vaccine.
Black and Latinx persons are at higher risk for certain autoimmune and inflammatory rheumatic diseases (AIRD) and have experienced worse COVID-19 outcomes compared to their white counterparts. Given the risks of severe COVID-19 outcomes such as hospitalization and death in people with AIRD, COVID-19 vaccine is recommended in this population. Historically, overall vaccine uptake among people with AIRDs has been low, and this vaccine reluctance has extended to COVID-19 vaccination. While additional COVID-19 vaccine doses have offered considerable added protection against severe outcomes, only 20% of all vaccinated persons in Alabama (AL) and 45% in Massachusetts have obtained an additional dose of COVID-19 vaccine as of October 2022. Racial and ethnic minority groups have faced disparities in obtaining subsequent COVID-19 vaccines, particularly in under-resourced communities, including those in Alabama and Massachusetts. Together, these obstacles exacerbate existing health inequities among people of color and perpetuate worse COVID-19 outcomes.
We will conduct a randomized controlled study to test an intervention that seeks to address gaps in COVID-19 vaccine information and access inequities common in Black and Latinx populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Storytelling" video including patient narratives, brochure and patient navigation | Experimental | Participants will review video with narratives on COVID-19 vaccination in patients with AIRD, receive brochure on the same topic; and interact with patient navigators. |
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| Attention Control: "Oral Health" video and "Oral Health" brochure | Active Comparator | Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences | Behavioral | Participants will watch video focused on the importance of receipt of updated COVID-19 vaccination in patients with AIRD |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of updated COVID-19 vaccination. | We will measure rates of receipt of updated COVID-19 vaccination. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
-Lack of access to phone
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary A Wilkenson, Clinical Research Coordinator, BS | Contact | 205-996-7875 | mawilkenson@uabmc.edu | |
| Paolo Rusconi, Project Director, PhD | Contact | paolorusconi@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maria I Danila, MD, MSc, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32379381 | Background | Feldman CH, Ramsey-Goldman R. Widening Disparities Among Patients With Rheumatic Diseases in the COVID-19 Era: An Urgent Call to Action. Arthritis Rheumatol. 2020 Sep;72(9):1409-1411. doi: 10.1002/art.41306. Epub 2020 Aug 9. No abstract available. | |
| 25659279 | Background | Hmamouchi I, Winthrop K, Launay O, Dougados M. Low rate of influenza and pneumococcal vaccine coverage in rheumatoid arthritis: data from the international COMORA cohort. Vaccine. 2015 Mar 17;33(12):1446-52. doi: 10.1016/j.vaccine.2015.01.065. Epub 2015 Feb 7. |
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| Video on the importance of good oral health for patients with AIRD | Behavioral | Participants will watch video on the importance of good oral health in AIRD patients. |
|
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| Brochure on COVID-19 vaccination in AIRD patients | Behavioral | Participants |
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| Patient Navigation | Behavioral | Participants will receive phone calls from patient navigators to provide support and information for receipt of updated COVID-19 vaccination in patients with AIRD |
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| Brochure on the importance of good oral health in AIRD patients | Behavioral | Participants will receive a brochure on the importance of good oral health in AIRD patients. |
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| Brigham Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Massachusetts Chan Medical School | Not yet recruiting | Worcester | Massachusetts | 01655 | United States |
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| 27096429 | Background | Costello R, Winthrop KL, Pye SR, Brown B, Dixon WG. Influenza and Pneumococcal Vaccination Uptake in Patients with Rheumatoid Arthritis Treated with Immunosuppressive Therapy in the UK: A Retrospective Cohort Study Using Data from the Clinical Practice Research Datalink. PLoS One. 2016 Apr 20;11(4):e0153848. doi: 10.1371/journal.pone.0153848. eCollection 2016. |
| 32621081 | Background | Boucher VG, Pelaez S, Gemme C, Labbe S, Lavoie KL. Understanding factors associated with vaccine uptake and vaccine hesitancy in patients with rheumatoid arthritis: a scoping literature review. Clin Rheumatol. 2021 Feb;40(2):477-489. doi: 10.1007/s10067-020-05059-7. Epub 2020 Jul 3. |
| 25667433 | Background | Hua C, Morel J, Ardouin E, Ricard E, Foret J, Mathieu S, Combe B, Lukas C. Reasons for non-vaccination in French rheumatoid arthritis and spondyloarthritis patients. Rheumatology (Oxford). 2015 Apr;54(4):748-50. doi: 10.1093/rheumatology/keu531. Epub 2015 Feb 8. No abstract available. |
| 31308211 | Background | Qendro T, de la Torre ML, Panopalis P, Hazel E, Ward BJ, Colmegna I, Hudson M. Suboptimal Immunization Coverage among Canadian Rheumatology Patients in Routine Clinical Care. J Rheumatol. 2020 May 1;47(5):770-778. doi: 10.3899/jrheum.181376. Epub 2019 Jul 15. |
| 34346564 | Background | Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4. |
| 32715660 | Background | Fernandez-Ruiz R, Masson M, Kim MY, Myers B, Haberman RH, Castillo R, Scher JU, Guttmann A, Carlucci PM, Deonaraine KK, Golpanian M, Robins K, Chang M, Belmont HM, Buyon JP, Blazer AD, Saxena A, Izmirly PM; NYU WARCOV Investigators. Leveraging the United States Epicenter to Provide Insights on COVID-19 in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2020 Dec;72(12):1971-1980. doi: 10.1002/art.41450. Epub 2020 Oct 28. |
| 33146001 | Background | Gianfrancesco MA, Leykina LA, Izadi Z, Taylor T, Sparks JA, Harrison C, Trupin L, Rush S, Schmajuk G, Katz P, Jacobsohn L, Hsu TY, D'Silva KM, Serling-Boyd N, Wallwork R, Todd DJ, Bhana S, Costello W, Grainger R, Hausmann JS, Liew JW, Sirotich E, Sufka P, Wallace ZS, Machado PM, Robinson PC, Yazdany J; COVID-19 Global Rheumatology Alliance. Association of Race and Ethnicity With COVID-19 Outcomes in Rheumatic Disease: Data From the COVID-19 Global Rheumatology Alliance Physician Registry. Arthritis Rheumatol. 2021 Mar;73(3):374-380. doi: 10.1002/art.41567. Epub 2021 Feb 2. |
| 33648855 | Background | Taylor T, Yazdany J, Gianfrancesco MA. The racial/ethnic and sociocultural aspects of the pandemic in rheumatology. Best Pract Res Clin Rheumatol. 2021 Mar;35(1):101665. doi: 10.1016/j.berh.2021.101665. Epub 2021 Feb 18. |
| 34450504 | Background | Raiker R, DeYoung C, Pakhchanian H, Ahmed S, Kavadichanda C, Gupta L, Kardes S. Outcomes of COVID-19 in patients with rheumatoid arthritis: A multicenter research network study in the United States. Semin Arthritis Rheum. 2021 Oct;51(5):1057-1066. doi: 10.1016/j.semarthrit.2021.08.010. Epub 2021 Aug 20. |
| 32796045 | Background | Pablos JL, Galindo M, Carmona L, Lledo A, Retuerto M, Blanco R, Gonzalez-Gay MA, Martinez-Lopez D, Castrejon I, Alvaro-Gracia JM, Fernandez Fernandez D, Mera-Varela A, Manrique-Arija S, Mena Vazquez N, Fernandez-Nebro A; RIER Investigators Group; RIER investigators group. Clinical outcomes of hospitalised patients with COVID-19 and chronic inflammatory and autoimmune rheumatic diseases: a multicentric matched cohort study. Ann Rheum Dis. 2020 Dec;79(12):1544-1549. doi: 10.1136/annrheumdis-2020-218296. Epub 2020 Aug 12. |
| 33955209 | Background | England BR, Roul P, Yang Y, Kalil AC, Michaud K, Thiele GM, Sauer BC, Baker JF, Mikuls TR. Risk of COVID-19 in Rheumatoid Arthritis: A National Veterans Affairs Matched Cohort Study in At-Risk Individuals. Arthritis Rheumatol. 2021 Dec;73(12):2179-2188. doi: 10.1002/art.41800. Epub 2021 Oct 19. |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D001327 | Autoimmune Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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