Chronic Disease Self-Management Program for Systemic Lupus Erythematosus

(WELL Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Chronic Disease Self-Management Program (CDSMP) can help African American women with systemic lupus erythematosus (SLE) manage their health better and reduce healthcare usage. SLE is a chronic disease where the immune system attacks the body, causing pain and fatigue. Participants will either join the CDSMP group or continue their usual care to determine if the program makes a difference. Women currently part of the Georgians Organized Against Lupus (GOAL) study who have not participated in the CDSMP in the last five years are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that may improve health management strategies for SLE.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Chronic Disease Self-Management Program (CDSMP) is safe for African American women with systemic lupus erythematosus?

Research has shown that the Chronic Disease Self-Management Program (CDSMP) helps individuals manage long-term illnesses more effectively. This program is easy for most to follow and teaches skills that boost confidence in handling health issues.

Studies have found that programs like the CDSMP can improve quality of life by reducing symptoms such as tiredness and pain. Importantly, no serious side effects have been linked to participation in the CDSMP, making it a safe choice for managing conditions like systemic lupus erythematosus (SLE).

The CDSMP has been tested with various groups and is already used to support individuals with different chronic conditions. This track record supports its safety. Participants often feel more in control of their health, leading to better overall outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Chronic Disease Self-Management Program (CDSMP) for systemic lupus erythematosus (SLE) because it offers a fresh approach to managing this complex condition. Unlike standard treatments for SLE, which typically include medications like corticosteroids and immunosuppressants to control inflammation and immune response, CDSMP focuses on empowering patients with self-management skills. This program helps patients take an active role in their own care, potentially leading to better health outcomes and improved quality of life. By teaching techniques to manage symptoms, communicate effectively with healthcare providers, and maintain healthy lifestyles, CDSMP provides a holistic approach that complements traditional medical treatments.

What evidence suggests that the Chronic Disease Self-Management Program is effective for systemic lupus erythematosus?

Studies have shown that self-management programs like the Chronic Disease Self-Management Program (CDSMP) can help people with long-term illnesses, including systemic lupus erythematosus (SLE), manage their symptoms better. Research indicates that these programs can lead to improvements, such as less pain and tiredness. In this trial, some participants will receive the CDSMP, which has been linked to increased self-confidence in managing health among African American women with SLE. Additionally, a small study found that the CDSMP helped low-income African American women with lupus achieve better health outcomes. This suggests that the CDSMP could effectively help people with lupus take control of their health and possibly reduce their need for healthcare services. ^{4 6 7 8 9}

Who Is on the Research Team?

Cristina M Drenkard, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Currently participating in the GOAL study

Exclusion Criteria

Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years

I have significant difficulties with my memory or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend the Chronic Disease Self-management Program (CDSMP) classes for 6 weeks

6 weeks

6 weekly classes (in-person)

Follow-up

Participants are monitored for health outcomes and healthcare utilization

18 months

Questionnaires at 4 select time periods

Long-term Follow-up

Participants' health outcomes are compared with the usual care group

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Chronic Disease Self-Management Program (CDSMP)

Trial Overview 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.

How Is the Trial Designed?

Group I: Chronic Disease Self-management Program (CDSMP) Active Control 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182245/

The Impact of Self-Management Interventions on ... Self-management interventions positively impact behavioral and clinical outcomes in individuals with SLE.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02988661

Women Empowered to Live With Lupus Study (WELL) This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with ...

3. lupus.bmj.com lupus.bmj.com/content/9/1/e000566

Cross-sectional study of the effects of self-efficacy on ... Symptom self-efficacy and treatment self-efficacy were inversely related to fatigue and pain interference in black women with SLE.

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.24811

Factors Associated With the Initiation and Retention of ... The Chronic Disease Self-Management Program (CDSMP) is designed to enhance patients' self-efficacy and skills to manage their chronic illness.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22936126/

Benefits of a self-management program in low-income ... We pilot tested the benefits of the CDSMP in low-income African American patients with SLE. CDSMP workshops were delivered to 49 African American women with SLE ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34738339/

Factors Associated With the Initiation and Retention ... Objective: The Chronic Disease Self-Management Program (CDSMP) is designed to enhance patients' self-efficacy and skills to manage their chronic illness.

7. stacks.cdc.gov stacks.cdc.gov/view/cdc/117051

Factors Associated with the Initiation and Retention of Patients ... Objective The Chronic Disease Self-Management Program (CDSMP) is designed to enhance patients self-efficacy and skills to manage their ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1568997224001009

The effects of lifestyle interventions on disease activity and ... Quality of life generally improved with physical activity (4 studies with in total 253 patients) and psychotherapy (9 studies with in total 623 patients), with ...

9. trials.arthritis.org trials.arthritis.org/trials/NCT02988661

Women Empowered to Live With Lupus Study This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with ...