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

699 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cristina M Drenkard, MD, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+