NCT06458075Recruiting
Intervention to Improve Communication and Medication Adherence in Lupus
Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 10 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Duke University
- Diseases
- Lupus (SLE)
- NCT number
- NCT06458075
What you commit to
- Study type: Interventional
- Planned participants: 480
- From 1 Jul 2024 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Clinician Inclusion Criteria:
- Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions
- Clinicians who have ambulatory rheumatology care at least ½ day per week
- Clinician Exclusion Criteria:
- Clinicians at Duke University who were involved in the investigators' pilot work
- Clinicians with an anticipated departure from the institution in the 12 months following enrollment
- Patient Inclusion Criteria:
- 18 years or older
- English-speaking, able to provide consent
- Diagnosed with SLE and receiving care with enrolled clinicians
- 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:
- Non-English speakers
- Patients who are prescribed only corticosteroids for SLE
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.