N/A
Completed N=699
Women Empowered to Live With Lupus Study
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT02988661 ↗
Enrolled (actual)
699
Serious AEs
—
Results posted
Mar 2022
Primary outcomePrimary: Communication With Physician - Stanford 3Q Scale Score — 3.1; 2.9; 3.3; 3.0 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Communication With Physician - Stanford 3Q Scale Score |
3.1; 2.9; 3.3; 3.0; 3.3; 3.0 | — |
| PRIMARY Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score |
46.1; 46.1; 47.0; 47.5; 46.2; 47.0 | — |
| PRIMARY PROMIS Global Health Physical Health Domain Score |
38.3; 40.6; 39.0; 40.0; 38.9; 40.3 | — |
| PRIMARY PROMIS Global Health Mental Health Domain Score |
41.5; 43.5; 42.4; 43.2; 42.4; 43.4 | — |
| PRIMARY PROMIS Physical Function Score |
38.4; 40.5; 38.4; 40.8; 39.0; 40.1 | — |
| PRIMARY PROMIS Pain Interference Score |
59.0; 57.7; 59.1; 57.6; 59.3; 57.9 | — |
| PRIMARY PROMIS Fatigue Score |
58.6; 57.6; 59.5; 57.5; 58.7; 57.8 | — |
| PRIMARY PROMIS Sleep Disturbance Score |
57.3; 56.6; 57.8; 55.8; 57.3; 56.5 | — |
| PRIMARY PROMIS Anxiety Score |
53.8; 52.0; 54.6; 50.5; 54.3; 52.0 | — |
| PRIMARY PROMIS Ability to Participate in Social Roles and Activities Score |
45.3; 47.4; 45.0; 47.1; 45.5; 46.6 | — |
| SECONDARY Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) |
12; 40; 25; 123; 72; 206 | — |
| SECONDARY PROMIS Adult Self-Efficacy Score |
47.1; 48.4; 47.5; 49.1; 48.2; 48.7 | — |
| SECONDARY PROMIS Anger Score |
53.2; 51.0; 53.5; 50.3; 52.7; 50.8 | — |
| SECONDARY Perceived Stress Scale 4 (PSS-4) Score |
6.2; 6.3; 6.2; 6.1; 6.0; 6.4 | — |
| SECONDARY Hospitalization Rate |
42.3; 45.5; 49.6; 47.8 | — |
| SECONDARY Emergency Department Visit Rate |
126.2; 121.3; 103.9; 111.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT02988661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.