Improving communication and medication adherence in lupus patients
Official title: Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
Run by Duke University · NCT06458075 · Data updated 2026-11-12
This study is testing a new program to help doctors and Black patients with lupus communicate better about their medications to see if it improves how well they stick to their treatment plans.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | October 2027 |
| Study ends | December 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06458075 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are English-speaking adults aged 18 and older diagnosed with systemic lupus erythematosus who are receiving care from enrolled clinicians.
✕Probably not a fit
Patients who are non-English speakers or those prescribed only corticosteroids for SLE may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This intervention aims to enhance communication between clinicians and patients with systemic lupus erythematosus (SLE) to improve medication adherence. The CO-LEAD program trains clinicians to use effective communication strategies, review pharmacy refill data, and collaboratively address adherence barriers with patients. Additionally, patients will utilize a validated questionnaire to identify and communicate their adherence challenges. The study focuses on addressing racial disparities in medication adherence among Black patients with SLE.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence and health outcomes for patients with lupus, particularly among Black patients who face unique challenges.
How similar studies have gone: While there have been various interventions aimed at improving medication adherence, this specific approach focusing on communication and addressing racial disparities is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Clinician Inclusion Criteria: 1. Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions 2. Clinicians who have ambulatory rheumatology care at least ½ day per week Clinician Exclusion Criteria: 1. Clinicians at Duke University who were involved in the investigators' pilot work 2. Clinicians with an anticipated departure from the institution in the 12 months following enrollment Patient Inclusion Criteria: 1. 18 years or older 2. English-speaking, able to provide consent 3. Diagnosed with SLE and receiving care with enrolled clinicians 4. Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR. Patient Exclusion Criteria: 1. Non-English speakers 2. Patients who are prescribed only corticosteroids for SLE 3. Patients who are accompanied by third-party member that is not willing or able to remain in the waiting room during the patient's visit and * Does not wish to be audio recorded * A minor without a parental/legal guardian and/or * Unable to give consent
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Kai Sun, MD — Duke University
- Study coordinator: Kai Sun, MD
- Email: kai.sun@duke.edu
- Phone: 919- 681- 7417
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.