CCCR Lupus Patient Navigator Program

Utilizing a Lupus Patient Navigator Program (LPNP) to Address Barriers to Care Related to Access to Preventive and Specialty Healthcare, Medication Adherence and Health Literacy in Systemic Lupus Erythematosus (SLE) for Minority Patients

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Behavioral: Patient Navigator Services

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Self-identified Minority.
2. Patients ≥ 18 years of age as documented in the electronic medical record.
3. Meeting either American College of Rheumatology or SLICC Classification Criteria for SLE as documented in the electronic medical record.
4. Ability to speak and understand English by self-report.
5. 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.
6. 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.
7. Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985) with properly executed Informed Consent Document and HIPAA Authorization.
8. Have telephone access.

Exclusion Criteria:

1. Unwilling or unable to give informed consent.
2. Being a prisoner or institutionalized individual.
3. Without telephone access.
4. Do not meet all of the inclusion criteria listed above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group	Behavioral: Patient Navigator Services; The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Quality of Life	Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses	12 months - from baseline to 12 month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Medication Adherence	Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between Lupus Patient Navigator Program (LPNP) participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence.	12 months - from baseline to 12 month visit
Improvement in Patient-reported Lupus-specific Disease Status	Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care.	12 months - from baseline to 12 month visit
Improvement in Adherence With Medical Providers and Services	Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients.	12 months - from baseline to 12 month visit

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); University of Alabama at Birmingham
• Investigators: Principal Investigator: Jim C. Oates, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 00095036; 3P30AR072582-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No