Online Support Program for Lupus

(WHEEL Trial)

Overseen By Dana Burshell, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Untreated mental illness, others

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

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online support program called Whole Health Empowerment for Endotypes of Lupus (WHEEL), designed to improve life quality for people with systemic lupus erythematosus (SLE), a condition that can cause fatigue, pain, and brain fog. The program helps participants set and achieve their own health goals with guidance from a health coach. Participants will attend online sessions and complete surveys to determine if this approach improves their daily life. The trial seeks women who have been part of the Duke Lupus Registry for at least a year and have recently visited the Duke Lupus Clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily living for those with SLE.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on an online support program rather than medication changes.

What prior data suggests that this online support program is safe for people with lupus?

Research has shown that the Whole Health Empowerment for Endotypes of Lupus (WHEEL) program is a new online support initiative designed to help individuals with systemic lupus erythematosus (SLE) enhance their quality of life. This program aims to alleviate symptoms such as fatigue, pain, and mental fog, which regular doctor visits often do not fully address.

As the program is neither a medication nor a medical procedure, it does not present typical safety concerns like side effects. Instead, participants join online sessions with a health coach to set personal health goals. The primary focus is on ensuring participants feel comfortable and supported during these sessions.

While specific safety data for WHEEL is unavailable, similar programs have been well-received, suggesting it is likely safe and well-tolerated. Participants can expect a supportive environment aimed at improving well-being without the usual risks associated with medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Whole Health Empowerment for Endotypes of Lupus (WHEEL) program is unique because it is an online support program specifically tailored to address different subtypes, or endotypes, of lupus. Unlike standard lupus treatments like immunosuppressants and corticosteroids, which primarily focus on reducing inflammation and suppressing the immune system, WHEEL aims to empower patients through personalized lifestyle and health management strategies. Researchers are excited about this approach because it could provide a more holistic and patient-centered way to manage lupus, potentially improving quality of life and long-term health outcomes without the side effects associated with traditional medications.

What evidence suggests that the WHEEL program is effective for improving quality of life in people with lupus?

Research has shown that the Whole Health Empowerment for Endotypes of Lupus (WHEEL) program, which participants in this trial may receive, can improve the quality of life for people with systemic lupus erythematosus (SLE). Early findings from related studies suggest that programs focusing on personal health goals and support effectively help with symptoms like tiredness, pain, and mental fog. While this program is still being tested in the trial, its approach of combining health coaching with personalized plans appears promising in managing these challenging symptoms. Initial data suggests this method could empower participants and lead to better health outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Rogers, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with systemic lupus erythematosus (SLE) who often experience fatigue, pain, and brain fog. Participants should be interested in engaging in an online support program that includes creating personal health goals and therapeutic plans.

Inclusion Criteria

ACR/EULAR criteria for SLE

Ability to speak and read English

Enrolled in the Duke Lupus Registry for ≥1 year

Exclusion Criteria

Significant cognitive impairment as determined by the treating rheumatologist

Untreated serious mental illness

Previous participation in WHEEL development

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the WHEEL program, consisting of eight virtual bi-weekly group sessions facilitated by a health coach, focusing on various aspects of SLE management.

16 weeks

8 virtual group sessions, 2 one-on-one virtual consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survey completion and assessment of intervention adherence.

10 months post-baseline

Wait-List Control (Delayed Intervention)

Participants in the wait-list control group receive the intervention after the immediate treatment group completes the program.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Whole Health Empowerment for Endotypes of Lupus (WHEEL)

Trial Overview The trial tests an 8-session online support program called WHEEL, led by a health coach. It aims to improve quality of life for lupus patients by addressing psychosocial and clinical factors beyond traditional clinic visits.

How Is the Trial Designed?

Group I: Group 2: Wait-List Control (Delayed Intervention) Experimental Treatment 1 Intervention

Group 2: Wait-List Control (Delayed Intervention) does not get the intervention while Group 1 is getting the intervention. Group 2 receives the intervention AFTER Group 1 has completed the intervention.

Group II: Group 1: Immediate Treatment Experimental Treatment 1 Intervention

Group 1 participants receive the intervention first which is completing the 4-month program. They will receive an additional survey when Group 2 completes the intervention.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Health disparities in systemic lupus erythematosus (SLE) are influenced by both genetic factors and social determinants of health, but research examining these combined effects is limited, leading to an incomplete understanding of the disease's impact across different racial and ethnic groups.

The authors propose a new framework for studying health disparities in SLE that aims to reduce bias in research, emphasizing the need for a more nuanced approach that considers both genetic and environmental factors in understanding disease outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reframing health disparities in SLE: A critical reassessment of racial and ethnic differences in lupus disease outcomes. Parodis, I., Lanata, C., Nikolopoulos, D., et al.[2023]

The Georgians Organized Against Lupus (GOAL) Research Cohort aims to address the lack of large, diverse patient groups in lupus research by providing a comprehensive database of clinical, biological, and sociodemographic information.

This cohort will enhance understanding of the interactions between various factors affecting lupus and may lead to targeted interventions to reduce health disparities in affected populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Lupus Disparities Through a Social Determinants of Health Framework: The Georgians Organized Against Lupus Research Cohort. Lim, SS., Drenkard, C.[2021]

In a study of 867 patients with systemic lupus erythematosus (SLE), changes in patient-reported outcomes were significantly associated with disease activity measures, indicating that improvements in disease activity lead to better patient-reported health scores.

Achieving the SLE responder index was linked to meaningful improvements in various health domains, with increases in scores for physical function and bodily pain, highlighting the importance of patient-reported outcomes in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial. Jolly, M., Annapureddy, N., Arnaud, L., et al.[2020]

Current lupus treatment trials face significant challenges, including large trial sizes, competition for patients, and complex outcome measures, which can lead to results that are difficult to interpret.

The authors propose new trial designs and strategies based on consultations with experts to enhance the likelihood of successful and interpretable lupus treatment development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lupus community panel proposals for optimising clinical trials: 2018. Merrill, JT., Manzi, S., Aranow, C., et al.[2022]

The study aims to create a dedicated module within the Hellenic Registry of Biologic Therapies to monitor Systemic Lupus Erythematosus (SLE) patients, focusing on disease activity, severity, and treatment outcomes, which will help assess the long-term efficacy and safety of biologic therapies like belimumab.

Registry-based studies allow for the inclusion of a broader patient population and long-term data collection, which can identify which disease phenotypes respond best to treatments and how co-existing conditions affect therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus. Adamichou, C., Flouri, I., Fanouriakis, A., et al.[2020]

A study involving 56 patients with systemic lupus erythematosus (SLE) found that nearly all participants (98.2%) had internet access, and 80% used the internet to manage their condition, indicating a strong reliance on digital resources.

Patients expressed a desire for more diverse and comprehensive online information about SLE, including understanding flares and sharing personal experiences, highlighting the potential for digital health interventions to enhance social support and education for SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspective on Using Digital Resources to Address Unmet Needs in Systemic Lupus Erythematosus. Ra, JH., Leung, J., Baker, EA., et al.[2022]

The WELL study successfully enrolled 168 African-American women with systemic lupus erythematosus (SLE) into a 6-week Chronic Disease Self-Management Program (CDSMP), achieving a 75% completion rate despite challenges in participant registration and attendance.

Key strategies for improving recruitment and retention included scheduling sessions on weekends, providing transportation services, and maintaining frequent contact with participants, which resulted in a high retention rate of 92.3% for the 6-month follow-up survey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. Drenkard, C., Easley, K., Bao, G., et al.[2022]

The web-based program MyLupusGuide was found to improve self-efficacy in participants with systemic lupus erythematosus (SLE), particularly benefiting those with initially low self-management skills and male participants, although it did not significantly increase overall patient activation scores.

Out of 541 participants, only 56% engaged with the MyLupusGuide site, indicating that while the program can enhance certain aspects of self-management, additional support may be necessary to encourage broader engagement and activation in self-management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the Impact of MyLupusGuide in Canada: Results of a Randomized Controlled Study. Fortin, PR., Neville, C., Julien, AS., et al.[2023]

In a study of 38 Portuguese patients with Systemic Lupus Erythematosus (SLE), belimumab demonstrated significant effectiveness, with SLE Responder Index (SRI) response rates increasing from 51.9% at 6 months to 91.7% at 24 months, indicating a reduction in disease activity.

Belimumab was associated with a good safety profile, with only five patients experiencing adverse events, primarily infections, and the treatment led to a significant decrease in disease activity markers and daily steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. Fernandes, BM., Barreira, S., Fonseca, JE., et al.[2021]

The ALPHA Project identified key barriers in lupus care and treatment through expert interviews and a global survey, categorizing them into drug development, clinical care, and access to care.

Top recommended solutions included simplifying outcome measures and defining the lupus spectrum, with leveraging social media receiving the highest feasibility score, highlighting the importance of digital technology in improving lupus management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research. Tse, K., Sangodkar, S., Bloch, L., et al.[2021]

Accurately measuring lupus disease activity is challenging due to the disease's complexity and variability, but several standardized instruments have shown reliability and sensitivity in detecting clinical improvement in observational studies and some randomized controlled trials.

The selection of disease activity endpoints for clinical trials must be tailored to specific outcomes and should prioritize simplicity and practicality, incorporating patient concerns while minimizing administrative burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Mikdashi, J., Nived, O.[2022]

The peer mentoring program for individuals with systemic lupus erythematosus (SLE) showed promising results, with mentees experiencing trends toward lower disease activity and improved health-related quality of life, including reduced anxiety and depression over a 12-week period.

Participants reported high satisfaction with the peer mentoring intervention, indicating that this approach is feasible and may enhance self-management and overall care for African American women with SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-to-Peer Mentoring for African American Women With Lupus: A Feasibility Pilot. Williams, EM., Hyer, JM., Viswanathan, R., et al.[2022]

A randomized controlled trial involving 80 patients with systemic lupus erythematosus showed that web-based education and counseling significantly improved self-efficacy, fatigue levels, and satisfaction with chronic illness care in the experimental group after six months.

The study highlights the potential of web-based interventions to enhance patient outcomes, suggesting that similar approaches could be beneficial for other patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care. Kankaya, H., Karadakovan, A.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06720584

Whole Health Empowerment for Endotypes of Lupus ... To address the quality-of-life limitations, the investigators have created and will test the health coach-led, 8-session Whole Health Empowerment for Endotypes ...

2. personalizedhealth.duke.edu personalizedhealth.duke.edu/our-work/current-projects/lupus-research-program

Lupus Research Program The objective of this study is to develop and test SLE-endotype-specific programs that empower participants to create and practice their personalized health ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06720584/whole-health-empowerment-for-endotypes-of-lupus-improving-quality-of-life-in-sle

Whole Health Empowerment for Endotypes of Lupus Whole Health Empowerment for Endotypes of Lupus: Improving Quality of Life in SLE · Phase · Condition · Treatment · Clinical Study ID.

4. withpower.com withpower.com/trial/phase-lupus-erythematosus-systemic-2-2025-9f42a

Online Support Program for Lupus (WHEEL Trial) What data supports the effectiveness of the treatment Whole Health Empowerment for Endotypes of Lupus (WHEEL)?. The WELL study showed that behavioral ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT06720584/ICF_000.pdf

Whole Health Empowerment for Endotypes of Lupus: ... • We will look at lupus-related data in your medical record to compare your pre-program and post-program experiences living with lupus. You ...

6. meddatax.com meddatax.com/clinical-trials/NCT06720584

Whole Health Empowerment for Endotypes of Lupus: Improving ... The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates. Basic Information. Get ...