Education and Navigation Program for Lupus

(LEAP Trial)

No longer recruiting at 1 trial location

Overseen By David Chae, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: None

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program to help people with systemic lupus erythematosus (SLE) better understand and manage COVID-19. The study compares two approaches: one group receives COVID-19 education and personalized guidance on testing and vaccination through the Vaccine Concierge (a personalized vaccine guidance service), while the other group receives education only. The trial seeks participants diagnosed with SLE who can speak and understand English. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance COVID-19 management for those with SLE.

Do I need to stop my current medications for this lupus trial?

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

What prior data suggests that this educational and navigation program is safe for people with lupus?

Research has shown that vaccines are generally safe for people with systemic lupus erythematosus (SLE). Studies have found that vaccines are crucial for SLE patients because infections can cause serious health issues.

In another study, most SLE patients received COVID-19 vaccines without major problems, indicating that these vaccines are well-tolerated. This evidence supports the idea that vaccines can be safely administered to people with SLE. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to address the unique needs of people with lupus (SLE) during the COVID-19 pandemic. Unlike the standard approach, which generally involves providing basic COVID information, this trial explores an "Education / Navigation" program. This program offers personalized guidance on testing and vaccination, specifically tailored for lupus patients. It helps participants navigate where and how to get tested and vaccinated, potentially easing the process and reducing anxiety. By focusing on individual needs and providing detailed information, this trial could improve health outcomes for those with lupus in a way that standard COVID-19 information doesn't.

What evidence suggests that this trial's treatments could be effective for people with lupus?

Research has shown that people with lupus often have a weaker immune response to COVID-19 vaccines compared to others. In this trial, the Vaccine Concierge treatment, part of the Education/Navigation arm, offers personalized advice on COVID-19 vaccination and testing. It helps lupus patients find testing options and schedule vaccination appointments, addressing their specific health needs. This customized approach aims to ensure patients receive timely and suitable care, possibly improving vaccine effectiveness for those with systemic lupus erythematosus (SLE). Early evidence suggests that such programs might lead to better health outcomes by making healthcare more accessible and tailored to individual needs. ^{5 6 7 8 9}

Who Is on the Research Team?

David H Chae, Sc.D., M.A.

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for adults over 18 living with systemic lupus erythematosus (SLE) in metropolitan Birmingham, Alabama. Participants must be able to speak and understand English. Those without a confirmed SLE diagnosis, under 18, or living outside the specified area cannot join.

Inclusion Criteria

Ability to speak and understand English

Living, working, or seeking care in Alabama or Louisiana

I have systemic lupus erythematosus (SLE).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education-only or navigation interventions on COVID-19 testing and vaccination

8 weeks

Follow-up

Participants are monitored for COVID testing and vaccination outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaccine Concierge

Trial Overview The study aims to compare the effectiveness of two approaches: one that provides only education about COVID-19 testing and vaccination, and another that includes navigation assistance to help people with SLE get tested or vaccinated against COVID-19.

How Is the Trial Designed?

Group I: Education / Navigation Experimental Treatment 1 Intervention

COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE; and (2) navigation, which involves individual tailoring of information about where and how to get tested, and where to get vaccinated, and when appropriate, guiding participants in scheduling testing and vaccination appointments.

Group II: Education Only Active Control 1 Intervention

COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

Xavier University of Louisiana.

Collaborator

Trials

9

Recruited

2,700+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

Published Research Related to This Trial

A study involving 422 patients with systemic lupus erythematosus (SLE) revealed a strong interest (70.4%) in a patient education program (PEP), highlighting their need for information on topics like pregnancy, disease outcomes, and treatment roles.

Feedback from a focus group and satisfaction questionnaires indicated that patients not only wanted information on managing symptoms but also expressed a need for better communication regarding their diagnosis and support for emotional challenges, leading to an adapted PEP that addresses these concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of patient needs to design a patient education program in systemic lupus erythematosus]. Hervier, B., Devilliers, H., Amiour, F., et al.[2016]

A team-based care coordination model can effectively address health care disparities in high-risk lupus patients, improving their management and outcomes.

Key intervention strategies should focus on access to care, behavioral modification, community outreach, education, and addressing mental health issues like depression to enhance the quality of care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing an Intervention to Improve Management of High-Risk Lupus Patients Through Care Coordination. Anandarajah, A.[2021]

The PREFERLUP study identified three distinct patient profiles among 268 lupus patients based on their treatment preferences, emphasizing the importance of considering individual preferences in medication decisions to improve adherence.

Most patients preferred oral medications with low side effects, while specific groups valued different treatment forms, such as implants or injections, indicating that personalized treatment plans could enhance patient acceptance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsupervised clustering analysis of data from an online community to identify lupus patient profiles with regards to treatment preferences. Testa, D., Jourde-Chiche, N., Mancini, J., et al.[2022]

The patient education program aims to empower individuals with lupus by teaching them strategies to prevent disease flares and develop coping skills for daily challenges.

Nurse specialists play a crucial role in delivering this education, highlighting the importance of a collaborative approach in managing systemic lupus erythematosus effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus. Part 2: The role of the nurse. Crofts, P., D'Cruz, D.[2019]

A multimodal educational activity significantly improved healthcare providers' knowledge about influenza and pneumococcal vaccinations, with post-test scores rising from 75% to 89% after the training.

The majority of providers (93%) reported increased awareness of vaccination importance for high-risk patients, and 55% planned to change their practice, indicating that education can effectively enhance vaccination rates in patients with systemic lupus erythematosus and other chronic inflammatory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician's Perceptions of a CME Activity to Increase Knowledge of Vaccination in Adults with Chronic Inflammatory Conditions. Sheikh, SZ., Iglesia, EGA., Underwood, M., et al.[2023]

The CALLS study, involving 30 participants, showed that a 12-week intervention with patient navigators significantly improved perceived self-efficacy in managing lupus compared to usual care.

While the intervention group experienced a slight decrease in disease flare scores, this change was not statistically significant, indicating that further research is needed to confirm long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Care-coordination Approach to Learning Lupus Self-Management: a patient navigator intervention for systemic lupus inpatients. White, AA., Ba, A., Faith, TD., et al.[2023]

The LT-PALS program effectively increased knowledge and intentions to participate in lupus clinical trials among participants, particularly benefiting those from underrepresented groups, with 46.9% of participants engaging in a trial within a year.

Participants who received peer-to-peer education reported higher self-efficacy and satisfaction with the program, especially among Black and Hispanic individuals, indicating the program's potential to improve diversity in clinical trial representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Utility of a Pilot Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials: Implementation and Evaluation in a Multisite Model Within a Lupus Clinical Trials Network. Sheikh, SZ., Donovan, C., Menezes, C., et al.[2023]

The online educational course significantly improved medical providers' knowledge, self-efficacy, and intentions to refer Black and Latino patients to lupus clinical trials, as shown by higher posttest scores in the intervention group compared to the control group.

The course was well-received, with high satisfaction ratings, indicating that effective education can enhance provider engagement in increasing minority participation in clinical trials for lupus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Provider-Based Approach to Address Racial Disparities in Lupus Clinical Trial Participation. Wanty, NI., Cooper, DL., Simkus, A., et al.[2023]

This study aims to evaluate a peer mentorship program specifically designed for African American women with systemic lupus erythematosus (SLE), which has shown promise in improving self-management and health-related quality of life based on preliminary data.

The intervention is innovative as it targets a demographic disproportionately affected by SLE, and it could serve as a model for future programs aimed at reducing health disparities in chronic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial. Williams, EM., Egede, L., Oates, JC., et al.[2022]

In a study involving 364 patients with systemic lupus erythematosus (SLE), long-term treatment with belimumab combined with standard therapy demonstrated a stable or declining incidence of adverse events over 4 years, indicating a favorable safety profile.

The most common side effects were mild, such as arthralgia and upper respiratory infections, and serious infusion reactions were rare, suggesting that belimumab can be safely administered for extended periods in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Merrill, JT., Ginzler, EM., Wallace, DJ., et al.[2013]

Vaccination against influenza significantly reduces the incidence of infection in patients with systemic lupus erythematosus (SLE), with pooled seroconversion rates between 46% and 56% and seroprotection rates from 68% to 73%, indicating effective immune response.

The study found that vaccination did not significantly affect disease activity scores in SLE patients, and reported flares were generally mild to moderate, suggesting that the vaccine is safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influenza Vaccination in Systemic Lupus Erythematosus: Efficacy, Effectiveness, Safety, Utilization, and Barriers. Sim, JJL., Lim, CC.[2022]

In a study of 73 patients with systemic lupus erythematosus (SLE), 84% showed a significant immune response to at least one of the vaccines (pneumococcal, tetanus toxoid, and Haemophilus influenzae type B), indicating that immunization is effective in this population.

The vaccines were found to be safe, with no significant impact on overall lupus disease activity, supporting the recommendation for SLE patients to receive vaccinations as per CDC guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antigen-specific antibody responses in lupus patients following immunization. Battafarano, DF., Battafarano, NJ., Larsen, L., et al.[2013]

Citations

1. nih.gov nih.gov/radx/funding

Funding | National Institutes of Health (NIH) Summary: This study will be a randomized comparative effectiveness trial examining contingency management as compared to contingency management ...

2. withpower.com withpower.com/trial/phase-lupus-erythematosus-systemic-3-2022-e9ce7

Education and Navigation Program for Lupus (LEAP Trial) The Vaccine Concierge treatment for lupus is unique because it involves a personalized approach, often referred to as concierge medicine, where patients receive ...

3. instagram.com instagram.com/p/DQKFzGek1Vg/

Navigating Traditional and Concierge Medicine Current treatments for systemic lupus erythematosus (SLE) include glucocorticoids, antimalarial agents, immunosuppressants, and biologic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11416733/

Anti-SARS-CoV-2 mRNA vaccination among patients living ... Several reports showed that the humoral response following vaccination was lower in SLE patients than the general population. However, real- ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMp2514232

Alive and Kicking: NOS Episode 3.1 But as I started to report on concierge medicine, quickly realizing that it was more a symptom of our broken primary care system than some ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4812392/

Vaccination of Adult Patients with Systemic Lupus ... As a whole, vaccination is safe and should be supported as part of standard of care in patients with SLE in whom infections are a significant cause of morbidity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2911868/

Provision of preventive health care in systemic lupus ... In this study, we examined two categories of preventive services in SLE: cancer surveillance (cervical, breast, and colon) and immunizations (influenza and ...

8. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.25094

Effect of Systemic Lupus Erythematosus and ... The risk of COVID-19 infection is increased in patients with systemic lupus erythematosus (SLE) versus those without SLE.

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/09612033241273052

Anti-SARS-CoV-2 mRNA vaccination among patients living ... By December 2021, 9% of both SLE and comparators had not received any vaccine doses. Among 5585 SLE patients and 37,102 comparators, 11 COVID-19 ...