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Search / Trial NCT06458075

Intervention to Improve Communication and Medication Adherence in Lupus

Launched by DUKE UNIVERSITY · Jun 10, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

ClinConnect Summary

The CO-LEAD trial is a study aimed at improving communication between doctors and patients with systemic lupus erythematosus (SLE), a chronic condition that can cause inflammation in different parts of the body. The goal is to help patients better follow their medication plans by teaching doctors effective communication strategies. This includes discussing when patients last refilled their prescriptions and identifying any challenges they face in taking their medications as prescribed. By using a special tool that helps patients explain their difficulties with medication adherence, the study hopes to create a more supportive environment for managing SLE.

To be eligible for this trial, participants must be at least 18 years old, speak English, and have a diagnosis of SLE while receiving care from participating doctors. They should also be taking at least one medication for their condition. During the trial, patients can expect to engage in open conversations with their healthcare providers about their medication routines and any obstacles they might be facing. This study is currently recruiting participants, and it’s important to note that non-English speakers or those only taking corticosteroids are not eligible to participate.

Gender

ALL

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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Kai Sun, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported