NCT06458075 Intervention to Improve Communication and Medication Adherence in Lupus
| NCT ID | NCT06458075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2024-07-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE). The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following: 1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers. 2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.
Eligibility 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
Contact & Investigator
Kai Sun, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06458075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06458075 currently recruiting?
Yes, NCT06458075 is actively recruiting participants. Contact the research team at kai.sun@duke.edu for enrollment information.
Where is the NCT06458075 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06458075 clinical trial?
NCT06458075 is sponsored by Duke University. The principal investigator is Kai Sun, MD at Duke University. The trial plans to enroll 480 participants.
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