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NCT Number: NCT07783152

Lupus Nephritis Care Pathway

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The Lupus Nephritis (LN) 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.

The investigators will include 25 patients with lupus nephritis. The study primarily assesses the LN Care Pathway's feasibility and acceptability using surveys, exit interviews, and metrics of enrollment, retention, and engagement. The investigators will also evaluate user experiences and identify areas for improvement in exit interviews. Lastly, the investigators will explore preliminary effects on medication adherence and key clinical outcomes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From study start through completion of enrollment

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Burshell, MPH

CONTACT

[email protected]

Edna Scarlett

CONTACT

[email protected]

919-684-6150

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Official study title

Evaluation of a Lupus Nephritis Care Pathway Integrating Telemedicine and Clinical Pharmacist Practitioners

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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