NCT06458075 · Duke University
Intervention to Improve Communication and Medication Adherence in Lupus
(CO-LEAD)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
CO-LEAD
The investigators will provide clinicians with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill data and the DOSE-Nonadherence-SLE survey, and engage and formulate solutions to adherence barriers together. The study team will provide the clinician intervention training in-person or virtually and will include didactics, demonstration, and practice that include two one-hour sessions one month apart. After training, CO-LEAD clinicians will be encouraged to incorporate the intervention in regular clinic visits with all patients.
Primary outcome measures
Frequency of adherence discussions
Time frame: During intervention period (up to 2 years)
Proportion of SLE patient visits in which a nonjudgmental, patient-centered adherence discussion took place as determined by analysis of clinic visit audio recordings
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations