Recruiting

Communication & Adherence

Sponsor:

Duke University

Code:

NCT06458075

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CO-LEAD

Study Details

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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT06458075

Start date

Jul 1, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control

Control clinicians will continue usual care.

active comparator: CO-LEAD

CO-LEAD clinicians will receive training in the intervention.

Interventions

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 measure

  • Frequency of adherence discussions [ Time Frame: During intervention period (up to 2 years) ]

Central Contacts and Locations

Central contacts

Kai Sun, MD

919- 681- 7417kai.sun@duke.edu

Kathyrn Pollak, PhD

919-681-4757Kathyrn.Pollak@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kai Sun

kai.sun@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-17.