Health TrialsbyHealthPanel

Lupus Nephritis Care Pathway

ConditionLupus Nephritis (LN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with severe cognitive impairment

Do not wish to receive longitudinal care at our health system

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Lupus Nephritis (LN) Care PathwayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From study start through completion of enrollment
2

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.

Time frame
6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Rheumatology Research Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: