N/A
N=75
CCCR Lupus Patient Navigator Program
Systemic Lupus Erythematosus (SLE)
Bottom Line
View on ClinicalTrials.gov: NCT04461158 ↗Enrolled (actual)
75
Serious AEs
—
Results posted
Aug 2024
Primary outcome: Primary: Improvement in Quality of Life — 59.2; 63.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Navigator Services (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Quality of Life |
59.2; 63.6 | — |
| SECONDARY Improvement in Medication Adherence |
— | — |
| SECONDARY Improvement in Patient-reported Lupus-specific Disease Status |
— | — |
| SECONDARY Improvement in Adherence With Medical Providers and Services |
— | — |
Summary
To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.
Eligibility Criteria
Inclusion Criteria
- Self-identified Minority.
- Patients ≥ 18 years of age as documented in the electronic medical record.
- Meeting either American College of Rheumatology or SLICC Classification Criteria for SLE as documented in the electronic medical record.
- Ability to speak and understand English by self-report.
- In the past six months having ≥ 1 missed clinic or diagnostic study/laboratory visit as documented in the electronic medical record, or self-reported failure to adhere with prescribed medical therapy for SLE.
- In the past six months having been prescribed at least one immunosuppressive medication for SLE activity as documented in the electronic medical record regardless of whether taking the medication.
- Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985) with properly executed Informed Consent Document and HIPAA Authorization.
- Have telephone access.
Exclusion Criteria
- Unwilling or unable to give informed consent.
- Being a prisoner or institutionalized individual.
- Without telephone access.
- Do not meet all of the inclusion criteria listed above.
Data sourced from ClinicalTrials.gov (NCT04461158). 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.