Intervention to Improve Communication and Medication Adherence in Lupus

NCT06458075 | Recruiting

• 2 other identifiers: Pro001153581R01MD018977-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Frequency of adherence discussions

  Proportion of SLE patient visits in which a nonjudgmental, patient-centered adherence discussion took place as determined by analysis of clinic visit audio recordings

  During intervention period (up to 2 years)

Secondary Outcomes (3)

• Quality of patient-clinician communication determined by audio recordings

  During intervention period (up to 2 years)

• Quality of patient-clinician communication determined by surveys

  During intervention period (up to 2 years)

• Change in SLE medication adherence

  Baseline and post-intervention (up to 6 months)

Study Arms (2)

Control

NO INTERVENTION

Control clinicians will continue usual care.

CO-LEAD

ACTIVE COMPARATOR

CO-LEAD clinicians will receive training in the intervention.

Behavioral: CO-LEAD

Interventions

CO-LEAD BEHAVIORAL

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.

CO-LEAD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kai Sun, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Sun, MD

CONTACT

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

Kathyrn Pollak, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)