Back to resultsCCCR Lupus Patient Navigator Program
Primary Purpose
Systemic Lupus Erythematosus (SLE)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigator Services
Sponsored by
About this trial
This is an interventional supportive care trial for Systemic Lupus Erythematosus (SLE)
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional Group
Arm Description
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04461158
First Posted
July 1, 2020
Last Updated
June 2, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04461158
Brief Title
CCCR Lupus Patient Navigator Program
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigator Services
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in Medication Adherence
Description
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 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.
Time Frame
12 months - from baseline to 12 month visit
Secondary Outcome Measure Information:
Title
Improvement in patient-reported lupus-specific disease status
Description
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.
Time Frame
12 months - from baseline to 12 month visit
Title
Improvement in Adherence with medical providers and services
Description
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.
Time Frame
12 months - from baseline to 12 month visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim C. Oates, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CCCR Lupus Patient Navigator Program
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