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Behavioral Intervention
Educational Materials for Rheumatic Diseases (TANGO Trial)
Birmingham, AL
N/A
Recruiting
Led By Maria I Danila, MD, MSc, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (18+ years) with known AIRD
Individuals who have not obtained the updated COVID-19 vaccine series (self-report)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find out if a new behavioral intervention in rheumatology clinics can help more people get the latest COVID-19 vaccine.
See full description
Who is the study for?
This trial is for adults over 18 with autoimmune rheumatic diseases (AIRD), specifically those of Black or Latinx ethnicity who haven't had the updated COVID-19 vaccine. Participants need phone access to join.Check my eligibility
What is being tested?
The study tests a new approach using brochures and videos about COVID-19 vaccination and oral health, plus patient narratives, to see if they encourage AIRD patients in clinics to get vaccinated.See study design
What are the potential side effects?
Since this trial focuses on educational materials rather than medications, there are no direct medical side effects. However, participants may experience changes in their perception or anxiety levels regarding vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Adults (18+ years) with known AIRD
Select...
I have not received the latest COVID-19 vaccine series.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Receipt of updated COVID-19 vaccination.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: "Storytelling" video including patient narratives, brochure and patient navigationExperimental Treatment3 Interventions
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.
Group II: Attention Control: "Oral Health" video and "Oral Health" brochureActive Control2 Interventions
Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910
Find a Location
Closest Location:University of Alabama at Birmingham· Birmingham, AL
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,675 Previous Clinical Trials
2,456,092 Total Patients Enrolled
1 Trials studying Autoimmune Diseases
800 Patients Enrolled for Autoimmune Diseases
National Institute on Minority Health and Health Disparities (NIMHD)NIH
468 Previous Clinical Trials
1,372,494 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
507 Previous Clinical Trials
1,088,615 Total Patients Enrolled
5 Trials studying Autoimmune Diseases
27,024 Patients Enrolled for Autoimmune Diseases
Maria I Danila, MD, MSc, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham