Lupus Nephritis Care Pathway

NCT07783152 | Not Yet Recruiting

• 1 other identifier: Pro00120423
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate an approach to managing patients with lupus nephritis called the Lupus Nephritis (LN) Pathway among approximately 25 patients. Activities include answering surveys and participating in an interview. Objectives include: 1) Assess feasibility and acceptability of the LN Care Pathway, 2) evaluate user experiences to identify opportunities for improvement, and 3) explore the preliminary effect of this pathway on medication adherence and clinical outcomes.

Conditions

Lupus Nephritis (LN)

Keywords

lupus nephritis

Outcome Measures

Primary Outcomes (5)

• Proportion of Eligible Patients Who Consent to and Enroll in the Study

  The proportion of eligible patients who provide informed consent and enroll in the study. Feasibility of recruitment will be supported if at least 70% of eligible patients consent to and enroll.

  From study start through completion of enrollment

• Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway

  The proportion of enrolled participants who complete the 6-month Lupus Nephritis Care Pathway. Feasibility of retention will be supported if at least 80% of enrolled participants complete the Care Pathway.

  6 months

• Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits

  The proportion of enrolled participants who complete at least 50% of planned telehealth visits during the 6-month Lupus Nephritis Care Pathway. Feasibility of participant engagement will be supported if at least 75% meet this threshold.

  6 months

• Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure

  The Feasibility of Intervention Measure is a 4-item measure of perceived feasibility. Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater feasibility. The mean score across items will be calculated.

  6 months

• Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure

  The Acceptability of Intervention Measure is a 4-item measure of perceived acceptability. Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater acceptability. The mean score across items will be calculated.

  6 months

Study Arms (1)

Lupus Nephritis (LN) Care Pathway

EXPERIMENTAL

All participants receive the same LN Care Pathway intervention.

Behavioral: Lupus Nephritis (LN) Care Pathway

Interventions

Lupus Nephritis (LN) Care Pathway BEHAVIORAL

The LN Care Pathway is an innovative, scalable, team-based model that leverages clinical pharmacist practitioners (CPPs) to deliver frequent telemedicine visits and implement protocol-based adherence support, medication management, and remote monitoring, all with oversight from rheumatology and nephrology physicians.

Lupus Nephritis (LN) Care Pathway

Eligibility Criteria

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

You may qualify if:

• Active patient at a Duke University Health System clinic
• Current diagnosis of Systemic Lupus Erythematosus (SLE) based on the 1997 ACR,32 2012 Systemic Lupus International Collaborating Clinics (SLICC),33 or 2019 European League Against Rheumatism (EULAR)/ACR (American College of Rheumatology)34 classification criteria
• Aged 18 years or older
• Able to provide informed consent
• Able to attend telemedicine visits
• New onset or ongoing active LN based on rheumatologist or nephrologist evaluation

You may not qualify if:

• Patients with severe cognitive impairment
• Do not wish to receive longitudinal care at our health system

Sponsors & Collaborators

• Rheumatology Research Foundation: collaborator
• Duke University: lead

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Kai Sun, MD, MS

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edna Scarlett

CONTACT

919-684-6150; edna.scarlett@duke.edu

Dana Burshell, MPH

CONTACT

dana.burshell@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share