Clinical trial NCT02988661: Women Empowered to Live With Lupus Study
Official title: A Widespread Self-management Education Program to Reduce Health Disparities in African American Women With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Autoimmunity
Immune System Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Centers for Disease Control and Prevention
First posted: 2016-12-09
Enrollment: 699
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Communication With Physician - Stanford 3Q Scale Score
timeFrame: Baseline, Months 6, 12, and 18
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Global Health Physical Health Domain Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Global Health Mental Health Domain Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Physical Function Score
timeFrame: Baseline, Months 6, 12, 18
measure: PROMIS Pain Interference Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Fatigue Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Sleep Disturbance Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Anxiety Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Ability to Participate in Social Roles and Activities Score
timeFrame: Baseline, Months 6, 12, 18
Secondary outcomes:
measure: Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Adult Self-Efficacy Score
timeFrame: Baseline, Months 6, 12, and 18
measure: PROMIS Anger Score
timeFrame: Baseline, Months 6, 12, and 18
measure: Perceived Stress Scale 4 (PSS-4) Score
timeFrame: Baseline, Months 6, 12, and 18
measure: Hospitalization Rate
timeFrame: Up to 2 years
measure: Emergency Department Visit Rate
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Cristina M Drenkard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drenkard C, Easley K, Bao G, Dunlop-Thomas C, Lim SS, Brady T. Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. Lupus Sci Med. 2020 Jun;7(1):e000391. doi: 10.1136/lupus-2020-000391.
citation: Twumasi AA, Shao A, Dunlop-Thomas C, Drenkard C, Cooper HLF. Health service utilization among African American women living with systemic lupus erythematosus: perceived impacts of a self-management intervention. Arthritis Res Ther. 2019 Jun 25;21(1):155. doi: 10.1186/s13075-019-1942-7.