Women Empowered to Live With Lupus Study (WELL)

Emory University

Status: Completed

Conditions: Lupus Erythematosus, Systemic

Treatments: Behavioral: Chronic Disease Self-management Program (CDSMP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02988661

R01MD010455 (U.S. NIH Grant/Contract)

IRB00003656

Details and patient eligibility

About

The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based self-management education program that has been shown to help people with chronic conditions to take control of their health problems. This study focuses on African American women with SLE because the CDSMP has not been widely studied in this population.

Full description

The CDSMP is an evidence-based, community-based, generic self-management program that consists of 6 weekly classes of two and a half hours each one, for six weeks. CDSMP classes are facilitated by certified peer leaders. Because the CDSMP is widely disseminated and available to the adult U.S. population through community centers, it may be a suitable and accessible option for African Americans with SLE, even though it is not specifically tailored to SLE or to African Americans. As the CDSMP has been primarily evaluated in predominantly white middle-class seniors with more common diseases (e.g. osteoarthritis, diabetes), the effectiveness of the CDSMP in helping African American women to self-manage SLE is unknown.

This study will examine the effectiveness of the CDSMP to improve patient-reported outcomes and reduce health care utilization in African American women with lupus. Using a two-group longitudinal cohort design with participants sampled from a parent population-based SLE cohort in Georgia, investigators will examine behaviors, health and healthcare outcomes, and the extent to which individual characteristics modify the effectiveness of the CDSMP.

The Georgians Organized Against Lupus (GOAL), a longitudinal cohort of patients with a validated diagnosis of SLE, will be used to enroll participants into the intervention. A random sample of African American women with SLE selected from the parent GOAL cohort will be recruited into the WELL (Women Empowered to Live with Lupus) cohort. WELL participants will attend the CDSMP classes in the community, along with people with other chronic illnesses. WELL participants will be asked to attend the CDSMP in the community and answer questionnaires at 4 select time periods before and after the program. Investigators will follow participant's progress for up to 18 months after they attend the CDSMP.

African American women from the GOAL cohort non-selected to be assigned to the intervention will comprise the usual care group. Participants will continue their longitudinal assessments as part of the GOAL cohort data collection efforts. Changes in outcomes for up to 18 months will be compared between WELL participants and the usual care group.

Enrollment: 699 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently participating in the GOAL study

Exclusion criteria

• Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
• Significant cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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699 participants in 2 patient groups

Chronic Disease Self-management Program (CDSMP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Chronic Disease Self-management Program (CDSMP)

Usual Care

No Intervention group

Description:

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.