Lupus Nephritis Care Pathway

Duke University

Status: Begins enrollment in 1 month

Conditions: Lupus Nephritis (LN)

Treatments: Behavioral: Lupus Nephritis (LN) Care Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT07783152

Pro00120423

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Lupus Nephritis (LN) Care Pathway

Experimental group

Description:

All participants receive the same LN Care Pathway intervention.

Treatment:

Behavioral: Lupus Nephritis (LN) Care Pathway