CCCR Lupus Patient Navigator Program

NCT04461158 | Completed Results

• 2 other identifiers: 000950363P30AR072582-03S1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement in Medication Adherence

  12 months - from baseline to 12 month visit

• Improvement in Patient-reported Lupus-specific Disease Status

  12 months - from baseline to 12 month visit

• Improvement in Adherence With Medical Providers and Services

  12 months - from baseline to 12 month visit

Study Arms (1)

Interventional Group

EXPERIMENTAL

Behavioral: Patient Navigator Services

Interventions

Patient Navigator Services BEHAVIORAL

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

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to give informed consent.
• Being a prisoner or institutionalized individual.
• Without telephone access.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Jim C. Oates, MD, Rheumatology Division Director
• Organization: Medical University of South Carolina

oatesjc@musc.edu

843-792-1991

Study Officials

• Jim C. Oates, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Division of Rheumatology & Immunology

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 8, 2020
• Study Start: September 3, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: March 9, 2026
• Results First Posted: August 6, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)