Educational Materials for Rheumatic Diseases

(TANGO Trial)

Recruiting at 2 trial locations

Overseen By Stephanie S Ford, Clinical Research Administration Manager, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Lack of phone access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1170 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Testimonials and Navigation for rheumatic diseases?

Research shows that patient education can improve knowledge, self-management, and quality of life for those with chronic diseases like rheumatic conditions. Digital education tools are highly accepted by patients and healthcare professionals, indicating they could effectively address unmet information needs and improve disease management. ^{1 2 3 4 5}

What safety data exists for treatments in rheumatic diseases?

Safety data for treatments in rheumatic diseases is being improved through better reporting of side effects in clinical trials and the use of real-world data from registries. These efforts aim to provide more accurate information on the safety of these treatments by including patient-reported outcomes and standardizing how side effects are reported. ^{6 7 8 9 10}

How is the 'Testimonials and Navigation' treatment for rheumatic diseases different from other treatments?

The 'Testimonials and Navigation' treatment is unique because it focuses on patient education through digital platforms, which helps patients better understand and manage their condition. Unlike traditional treatments that may focus solely on medication, this approach emphasizes improving patients' knowledge and self-management skills, potentially leading to better long-term outcomes. ^{1 11 12 13 14}

Research Team

Maria I Danila, MD, MSc, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Adults (18+ years) with known AIRD

Black race and/or Latinx ethnicity

I have not received the latest COVID-19 vaccine series.

Exclusion Criteria

Lack of access to phone

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants review storytelling video with patient narratives on COVID-19 vaccination, receive a brochure, and interact with patient navigators

3 months

Follow-up

Participants are monitored for receipt of updated COVID-19 vaccination

3 months

Treatment Details

Interventions

• Testimonials and Navigation

Trial Overview 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.

Participant Groups

Group I: "Storytelling" video including patient narratives, brochure and patient navigation Experimental Treatment 3 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" brochure Active Control 2 Interventions

Participants will review video on the importance of oral health in patients with AIRD and receive brochure on the same topic.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

A survey of 254 rheumatic patients revealed that only 24% felt well-informed about their disease, highlighting a significant gap in patient education compared to specialized rheumatology nurses' estimates of 42%.

Patients expressed a strong interest in using digital education tools, with 89% indicating they would likely use a mobile application to learn about their condition, suggesting a promising avenue for improving disease management through technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet Information Needs of Patients with Rheumatic Diseases: Results of a Cross-Sectional Online Survey Study in Germany. Becker, C., Diener, M., Hueber, AJ., et al.[2022]

Patient education significantly improves knowledge, self-efficacy, and health status in patients with chronic diseases, as shown in various studies, particularly in rheumatic diseases.

Incorporating physical training or rehabilitation into patient education programs leads to better outcomes, although the effect sizes for specific disease outcomes are generally low to moderate and short-lived.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education in rheumatologic care--a review]. Genth, E.[2021]

A survey of 1159 health professionals across Europe and Asia showed high agreement with the EULAR recommendations for patient education in rheumatology, but lower applicability due to barriers like lack of time and training.

Identified facilitators for better implementation included tailoring education to individual needs and using group sessions, suggesting that improving training and evaluation tools could enhance the effectiveness of patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing acceptability and identifying barriers and facilitators to implementation of the EULAR recommendations for patient education in inflammatory arthritis: a mixed-methods study with rheumatology professionals in 23 European and Asian countries. Bennett, SE., Zangi, HA., Larsson, I., et al.[2022]

A study analyzing 32 websites about dermatomyositis and polymyositis found that the overall quality of information was low, with a median DISCERN score of only 38 out of 80, indicating that most sources do not provide reliable guidance for patients.

The readability of the information was also poor, suggesting that patients may struggle to understand the content, which is crucial for making informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of internet-based information on dermatomyositis and polymyositis. Haque, A., Cox, M., Sandler, RD., et al.[2021]

A study involving 895 patients with rheumatic diseases identified ten distinct health literacy profiles, revealing that 42% of patients had moderate to high health literacy, while 16% struggled significantly across most domains.

The identified health literacy profiles were consistent regardless of the type of rheumatic disease or the hospital, suggesting that tailored health literacy interventions can be developed for a broad range of patients in rheumatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Health Literacy Needs in Rheumatology: Which Patient Health Literacy Profiles Need the Attention of Health Professionals? Bakker, MM., Putrik, P., Rademakers, J., et al.[2021]

The establishment of European biologics registers for rheumatic diseases is crucial for improving drug safety assessments, and a set of seven key considerations has been identified to guide the creation of these registers.

To enhance the quality and interpretability of safety data, nine additional points for analysis and reporting have been proposed, emphasizing the importance of thoughtful design and harmonization in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Dixon, WG., Carmona, L., Finckh, A., et al.[2022]

Observational studies and registries in rheumatology provide valuable real-world data on the safety and effectiveness of treatments, emphasizing the importance of proper study design and analysis.

The increasing interest in real-world effectiveness data is expected to lead to a rise in registries, which can offer timely insights into rheumatic treatments due to their detailed clinical information and advanced analytical tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods to analyze real-world databases and registries. Kremers, HM.[2009]

A systematic review of 93 randomized controlled trials involving 31,023 patients revealed a total of 21,498 adverse events (AEs), with 58% of these AEs being suitable for self-reporting by patients, highlighting the importance of patient perspectives in understanding treatment harms.

The study found a lack of systematic reporting on the severity of AEs, with only 9% of trials providing discernible severity grading, indicating a need for standardized frameworks to improve harm reporting in rheumatology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. Berthelsen, DB., Woodworth, TG., Goel, N., et al.[2021]

A study involving 34 patients with rheumatic and musculoskeletal diseases identified up to 171 important items related to safety and harms that patients experience during clinical trials.

The OMERACT community largely agreed (96%) that there is sufficient qualitative data to proceed with developing a Delphi survey to better understand and measure patient-reported safety and harm in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group. Berthelsen, DB., Simon, LS., Ioannidis, JPA., et al.[2023]

The OMERACT initiative aims to create a standardized tool for reporting adverse events in rheumatology clinical trials, which will help ensure consistent terminology and severity assessment across studies.

The proposed Rheumatology Common Toxicity Criteria Index covers multiple organ systems, but its effectiveness and practicality must be validated in clinical trials before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. Woodworth, TG., Furst, DE., Strand, V., et al.[2007]

A new website dedicated to providing information about systemic lupus erythematosus (SLE) was used by 20-30 users daily over a 24-month study period, demonstrating its popularity and accessibility for patients seeking information.

Knowledge assessments showed a significant increase in understanding of SLE among users after visiting the site, indicating that online resources can effectively enhance patient education and may be more cost-effective than traditional printed materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and assessment of a World Wide Web site for systemic lupus erythematosus patient information. Young, SP., Henderson, E., Cheseldine, DL., et al.[2017]

AI/Learn/Rheumatology is an innovative computer-assisted interactive system designed to improve the education of health professionals about rheumatic diseases, utilizing visual and problem-solving techniques.

The system is effective for teaching various groups, including medical students and primary care physicians, making learning enjoyable and suitable for both small groups and independent study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AI/Learn/Rheumatology. A computer-assisted educational system for teaching about rheumatic diseases. Bridges, AJ., Dansdill, D., Anderson, J., et al.[2019]

Patient education programs developed by the German Society of Rheumatology have effectively improved knowledge and self-efficacy in patients with various rheumatic diseases, including rheumatoid arthritis and lupus.

Randomized studies show that these programs not only enhance self-help activities but also reduce pain and disability related to arthritis, demonstrating their efficacy in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality assurance of rheumatologic patient education]. Langer, HE., Ehlebracht-König, I., Mattussek, S.[2008]

Patient education is crucial for managing chronic rheumatic diseases, as it has been shown to improve coping strategies, reduce pain and depression, and decrease feelings of helplessness among patients.

The German Society of Rheumatology has developed a structured patient education program for rheumatoid arthritis, consisting of six group sessions led by an interdisciplinary team, which serves as a model for future programs targeting other rheumatic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education--a contribution to improvement of long-term management of patients with rheumatism]. Langer, HE.[2007]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Unmet Information Needs of Patients with Rheumatic Diseases: Results of a Cross-Sectional Online Survey Study in Germany. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Patient education in rheumatologic care--a review]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Assessing acceptability and identifying barriers and facilitators to implementation of the EULAR recommendations for patient education in inflammatory arthritis: a mixed-methods study with rheumatology professionals in 23 European and Asian countries. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of internet-based information on dermatomyositis and polymyositis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Addressing Health Literacy Needs in Rheumatology: Which Patient Health Literacy Profiles Need the Attention of Health Professionals? [2021]

6. England pubmed.ncbi.nlm.nih.gov

EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Methods to analyze real-world databases and registries. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Development and assessment of a World Wide Web site for systemic lupus erythematosus patient information. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

AI/Learn/Rheumatology. A computer-assisted educational system for teaching about rheumatic diseases. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Quality assurance of rheumatologic patient education]. [2008]

14. Germany pubmed.ncbi.nlm.nih.gov

[Patient education--a contribution to improvement of long-term management of patients with rheumatism]. [2007]