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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)

Who can join

Ages 18 to 90 · All sexes

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 the study

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.

What is being tested

• CO-LEAD (behavioral)

Sponsor: Duke University · Participants: 480 · Started: Jul 1, 2024

Contact the study team

• Kai Sun, MD · Phone: 919- 681- 7417
• Kathyrn Pollak, PhD · Phone: 919-681-4757

Official record on ClinicalTrials.gov — NCT06458075

Locations in the U.S.

Conditions

• Lupus

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.