What side effects are associated with this type of intervention?

Common treatments for Systemic Lupus Erythematosus (SLE) include hydroxychloroquine, glucocorticoids, and immunosuppressive agents. Hydroxychloroquine can cause ocular, gastrointestinal, hematologic, and neurologic side effects, with a risk of irreversible retinopathy. Glucocorticoids may lead to weight gain, osteoporosis, hypertension, and increased infection risk. Immunosuppressive agents like azathioprine and belimumab can cause bone marrow suppression, liver toxicity, and increased susceptibility to infections. These treatments are often part of a comprehensive self-management approach to improve health outcomes and reduce healthcare use in SLE patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Systemic Lupus Erythematosus (SLE), including hydroxychloroquine, which is recommended for all patients with SLE due to its broad efficacy and safety profile. For patients with moderate to severe disease, additional immunosuppressive agents such as azathioprine, belimumab, and anifrolumab are often used. These treatments aim to control disease activity and prevent organ damage. While the Chronic Disease Self-management Program (CDSMP) focuses on self-management education to improve health outcomes, it complements these pharmacologic treatments by empowering patients to manage their condition effectively.

What other types of research exist?

Promising alternatives to the Chronic Disease Self-management Program (CDSMP) for SLE patients include: 1) Digital health interventions such as mobile apps and telehealth platforms that provide personalized self-management education and support. 2) Integrative approaches combining cognitive-behavioral therapy (CBT) with physical activity programs tailored for SLE patients. 3) Peer support programs that connect patients with trained peer mentors who have successfully managed their condition. 4) Comprehensive lifestyle interventions focusing on diet, exercise, and stress management, customized for SLE patients. These alternatives leverage technology and holistic approaches to enhance patient engagement and outcomes.

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Chronic Disease Self-Management Program for Systemic Lupus Erythematosus (WELL Trial)

N/A

Waitlist Available

Led By Cristina M Drenkard, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if a health education program can improve health and reduce healthcare use in African American women with lupus. The program involves regular sessions that teach practical skills for managing health problems. Researchers want to see if this helps these women better manage their condition. This community-based education program is designed to help participants gain confidence and skills to better manage their chronic conditions; it has been implemented worldwide.

Who is the study for?

This study is specifically for African American women who are already part of the GOAL study and have systemic lupus erythematosus (SLE). It's not open to those who've done the Chronic Disease Self-Management Program in the last five years or have significant cognitive impairment.

What is being tested?

The trial is testing if a program called Chronic Disease Self-Management Program can help improve health outcomes and reduce healthcare usage for African American women with SLE, as it hasn't been widely studied in this group before.

What are the potential side effects?

Since CDSMP is an educational program rather than a medication, there aren't typical drug side effects. However, participants may experience stress or discomfort when discussing personal health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Communication With Physician - Stanford 3Q Scale Score

PROMIS Ability to Participate in Social Roles and Activities Score

PROMIS Anxiety Score

+7 more

Secondary study objectives

Emergency Department Visit Rate

Hospitalization Rate

Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Chronic Disease Self-management Program (CDSMP)Active Control1 Intervention

A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort will be used to recruit participants into the CDSMP. This group will be identified as the WELL Cohort.

Group II: Usual CareActive Control1 Intervention

African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who have not been selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Systemic Lupus Erythematosus (SLE) include hydroxychloroquine, NSAIDs, and glucocorticoids. Hydroxychloroquine works by modulating the immune system and reducing inflammation, which helps control lupus symptoms and prevent flares. NSAIDs alleviate pain and inflammation, providing symptomatic relief for joint and muscle pain. Glucocorticoids are potent anti-inflammatory agents that suppress the immune response, reducing tissue damage during severe flares. These treatments are crucial for SLE patients as they help manage chronic symptoms, prevent disease progression, and improve quality of life. The Chronic Disease Self-management Program (CDSMP) complements these treatments by empowering patients with self-management skills, potentially leading to better health outcomes and reduced healthcare utilization.

[Clinical practice guidelines for systemic lupus erythematosus: Recommendations for general clinical management].