Testimonials and Navigation in Rheumatology

NCT06469788 | Recruiting

• 2 other identifiers: IRB-3000121685R01MD019235
• Study Type: interventional
• Target: 1,170
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rheumatologic Disease; Autoimmune Diseases

Keywords

COVID-19 vaccination; Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• Receipt of updated COVID-19 vaccination.

  We will measure rates of receipt of updated COVID-19 vaccination.

  3 months

Study Arms (2)

"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.

Behavioral: Video comprised of AIRD patient narratives on COVID-19 vaccination thoughts and experiences; Behavioral: Brochure on COVID-19 vaccination in AIRD patients; Behavioral: Patient Navigation

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.

Behavioral: Video on the importance of good oral health for patients with AIRD; Behavioral: Brochure on the importance of good oral health in AIRD patients

Interventions

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.

Also known as: Attention Control

Attention Control: "Oral Health" video and "Oral Health" brochure

Brochure on COVID-19 vaccination in AIRD patients BEHAVIORAL

Participants

"Storytelling" video including patient narratives, brochure and patient navigation

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.

Attention Control: "Oral Health" video and "Oral Health" brochure

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

"Storytelling" video including patient narratives, brochure and patient navigation

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

"Storytelling" video including patient narratives, brochure and patient navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18+ years) with known AIRD
• Black race and/or Latinx ethnicity
• Individuals who have not obtained the updated COVID-19 vaccine series (self-report)

You may not qualify if:

• Lack of access to phone

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Brigham Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

NOT YET RECRUITING

Related Publications (13)

• 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.

  PMID: 32379381 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.

  PMID: 25659279 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.

  PMID: 27096429 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.

  PMID: 32621081 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.

  PMID: 25667433 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.

  PMID: 31308211 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.

  PMID: 34346564 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.

  PMID: 32715660 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.

  PMID: 33146001 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.

  PMID: 33648855 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.

  PMID: 34450504 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.

  PMID: 32796045 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.

  PMID: 33955209 BACKGROUND

MeSH Terms

Conditions

Collagen Diseases; Autoimmune Diseases; Rheumatic Diseases

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Maria I Danila, MD, MSc, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary A Wilkenson, Clinical Research Coordinator, BS

CONTACT

205-996-7875; mawilkenson@uabmc.edu

Paolo Rusconi, Project Director, PhD

CONTACT

paolorusconi@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)