Education and Navigation Program for Lupus

(LEAP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tulane University

Disqualifiers: None

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial examines the impact of different types of support on COVID-19 testing and vaccination for people with systemic lupus erythematosus.

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 data supports the effectiveness of the Education and Navigation Program for Lupus treatment?

Research shows that educational activities can increase vaccination rates in patients with chronic inflammatory conditions like lupus, and care coordination strategies can improve management and outcomes for high-risk lupus patients. ^{1 2 3 4 5}

Is the Education and Navigation Program for Lupus safe for humans?

The research on influenza vaccination in lupus patients shows that vaccines are generally safe, with mild to moderate flares reported, and no significant change in disease activity scores after vaccination. This suggests that similar educational and navigation programs for lupus, which may include vaccine guidance, are likely safe for humans. ^{4 6 7 8 9}

How is the Vaccine Concierge treatment for lupus different from other treatments?

The Vaccine Concierge treatment for lupus is unique because it involves a personalized approach, often referred to as concierge medicine, where patients receive tailored care and guidance, which is not typically part of standard lupus treatments. This approach may include direct access to healthcare providers and customized health plans, focusing on individual patient needs rather than a one-size-fits-all treatment. ^{4 8 10 11 12}

Research Team

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

Principal Investigator

Tulane University

Eligibility Criteria

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 am 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

• Vaccine Concierge (Behavioral Intervention)

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.

Participant Groups

Group I: Navigation Experimental Treatment 1 Intervention

COVID education for people with lupus and tailored guidance in vaccination and testing for COVID and making appointments.

Group II: Education Active Control 1 Intervention

COVID education for people with lupus.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

J. Christian Winters

Louisiana State University Health Sciences Center in New Orleans

Chief Executive Officer

MD

Jayne Weiss

Louisiana State University Health Sciences Center in New Orleans

Chief Medical Officer

MD

Xavier University of Louisiana.

Collaborator

Trials

9

Recruited

2,700+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Ochsner Health System

Collaborator

Trials

97

Recruited

91,900+

Pete November

Ochsner Health System

Chief Executive Officer since 2022

JD from Louisiana State University

Robert Hart

Ochsner Health System

Chief Medical Officer since 2022

MD

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

Clinician's Perceptions of a CME Activity to Increase Knowledge of Vaccination in Adults with Chronic Inflammatory Conditions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The Care-coordination Approach to Learning Lupus Self-Management: a patient navigator intervention for systemic lupus inpatients. [2023]

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

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

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Unsupervised clustering analysis of data from an online community to identify lupus patient profiles with regards to treatment preferences. [2022]

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

Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]

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

Antigen-specific antibody responses in lupus patients following immunization. [2013]

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

A Provider-Based Approach to Address Racial Disparities in Lupus Clinical Trial Participation. [2023]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Systemic lupus erythematosus. Part 2: The role of the nurse. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Assessment of patient needs to design a patient education program in systemic lupus erythematosus]. [2016]

12. England 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. [2022]