Communication and Medication Adherence Intervention for Lupus

(CO-LEAD Trial)

Overseen By Kathyrn Pollak, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: SLE medications

Must not be taking: Only corticosteroids

Disqualifiers: Non-English speakers, minors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called CO-LEAD to enhance communication between doctors and patients, aiming to help people with lupus adhere better to their medication plans. Lupus patients often struggle with medication adherence, and this trial seeks to facilitate discussions between patients and doctors about these challenges. One part of the trial trains doctors in improved communication strategies, while another helps patients identify and discuss their medication challenges. Patients with lupus who take at least one medication (beyond just steroids) and fill prescriptions at pharmacies linked to a specific reporting system may be suitable for this trial.

As an unphased trial, this study provides a unique opportunity for patients to contribute to improving communication strategies in lupus care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving communication and medication adherence, so it's likely you will continue your current medications.

What prior data suggests that this intervention is safe for improving communication and medication adherence in lupus patients?

Research has shown that better communication between doctors and patients can help manage conditions like lupus. The CO-LEAD program aims to improve how doctors discuss medication habits with patients and address any challenges in following treatment plans.

In terms of safety, the CO-LEAD program serves as a communication and support tool, not a medication. Therefore, it doesn't carry the risks associated with new drugs. It is designed to enhance conversations between patients and doctors, helping patients understand and adhere to their treatment more effectively.

Since CO-LEAD focuses on improving communication and does not involve a new drug, there have been no reports of negative effects or side effects from the program itself. The goal is to facilitate collaboration between patients and doctors in managing lupus effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CO-LEAD because it focuses on enhancing communication and medication adherence for people with lupus, which is a fresh take compared to traditional lupus treatments like immunosuppressants and corticosteroids. Unlike these medications that target the immune system directly, CO-LEAD aims to empower clinicians with specialized training to improve patient interactions and support. This approach could lead to better patient outcomes by ensuring that individuals adhere more consistently to their prescribed treatments, potentially reducing lupus flares and improving quality of life.

What evidence suggests that the CO-LEAD intervention is effective for improving communication and medication adherence in lupus patients?

Research has shown that better communication between doctors and patients can help people with systemic lupus erythematosus (SLE) adhere to their medication regimen more consistently. In this trial, participants in the CO-LEAD arm will receive the intervention, which studies have shown led 44% of patients to improve their medication habits by 20% or more. This improvement means they were more likely to take their medication as directed. The CO-LEAD program trains doctors to communicate more effectively about medication use and helps them understand the challenges patients face. By incorporating patients' feedback, the program aims to make treatment plans more effective and tailored to each individual. ^{1 6 7 8 9}

Who Is on the Research Team?

Kai Sun, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adult rheumatology professionals and fellows at two academic institutions who provide outpatient care at least half a day per week. It aims to improve how they communicate with lupus patients about medication use.

Inclusion Criteria

I am a rheumatology professional (doctor, nurse, or fellow) at one of the two specified academic institutions.

I am under the care of a doctor.

I provide outpatient care for rheumatology patients at least half a day every week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians receive training on effective communication strategies and medication adherence assessment using the CO-LEAD intervention

up to 2 years

Regular training sessions and feedback

Follow-up

Participants are monitored for communication and adherence outcomes

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• CO-LEAD

Trial Overview The CO-LEAD intervention is being tested to see if it helps doctors talk more effectively with lupus patients, leading to better understanding and management of their medications.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Control clinicians will continue usual care.

Group II: CO-LEAD Active Control 1 Intervention

CO-LEAD clinicians will receive training in the intervention.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A pilot intervention using pharmacy refill data to monitor medication adherence in 130 patients with systemic lupus erythematosus (SLE) showed high feasibility and acceptability among providers and patients, with implementation documented in 89% of clinic notes.

The intervention led to a statistically significant increase in medication adherence, with the proportion of patients achieving a medication possession ratio (MPR) of 80% or higher rising from 48% to 58% after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. Sun, K., Eudy, AM., Rogers, JL., et al.[2023]

Only 25% of patients with systemic lupus erythematosus (SLE) achieved an adherence rate of 80% or higher to their prescribed oral therapies over a two-year period, as monitored by an electronic system.

Non-adherence was significantly associated with higher levels of depression and the number of medications taken daily, indicating that mental health and medication burden may impact treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring therapeutic adherence in systemic lupus erythematosus with electronic monitoring. Marengo, MF., Waimann, CA., de Achaval, S., et al.[2022]

In a study of 77 patients with systemic lupus erythematosus (SLE), nearly half (48%) exhibited persistent medication nonadherence, particularly among younger Black patients with lower income and more severe disease.

Factors contributing to nonadherence included hurried communication from healthcare providers and lower self-efficacy in managing medications, suggesting that improving communication and support could enhance adherence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Hurried Communication and Low Patient Self-Efficacy With Persistent Nonadherence to Lupus Medications. Barr, AC., Clowse, M., Maheswaranathan, M., et al.[2023]

A study involving 205 patients with systemic lupus erythematosus (SLE) identified various reasons for medication non-adherence, including forgetfulness, distrust in medications, and poor communication with healthcare providers.

To improve adherence, the study suggests several interventions such as enhancing communication between patients and healthcare professionals, providing better education about medications, and ensuring consistent healthcare support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Can We Enhance Adherence to Medications in Patients with Systemic Lupus Erythematosus? Results from a Qualitative Study. Emamikia, S., Gentline, C., Enman, Y., et al.[2022]

In a study of 94 patients with systemic lupus erythematosus, only 48% were found to be compliant with their medication regimens, highlighting a significant issue in treatment adherence.

Interestingly, higher education levels were linked to non-compliance, while Spanish-speaking patients and those earning over $15,000 annually showed better compliance, suggesting that cultural and socioeconomic factors play a crucial role in medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Education is Associated with Decreased Compliance in an Urban Multi-Ethnic Lupus Cohort. Gross, R., Graybill, J., Wahezi, D., et al.[2020]

Patients with systemic lupus erythematosus (SLE) from racially and socioeconomically diverse backgrounds reported a twofold higher non-adherence to hydroxychloroquine (HCQ), primarily due to concerns about side effects and logistical barriers.

A tailored adherence intervention was developed based on patient and healthcare advisor feedback, focusing on strategies like co-pay assistance and personal reminders to address specific barriers to HCQ adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and healthcare team recommended medication adherence strategies for hydroxychloroquine: results of a qualitative study informing intervention development. Garg, S., Chewning, B., Gazeley, D., et al.[2022]

A study involving 186 survey participants and 23 in-depth interviews found that patient satisfaction and adherence to lupus medication are significantly influenced by the quality of the physician-patient relationship, particularly the physician's listening skills.

Patients with past adverse medical experiences reported lower satisfaction and adherence, highlighting the need for healthcare providers to consider patients' self-reported symptoms and quality of life in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication decision-making and adherence in lupus: patient-physician discordance and the impact of previous 'adverse medical experiences'. Sloan, M., Lever, E., Gordon, C., et al.[2022]

African American and white women with systemic lupus erythematosus (SLE) showed similar rates of medication nonadherence, but African Americans were more likely to attend clinic appointments, indicating that adherence behaviors may differ by ethnicity.

Barriers to treatment adherence varied by ethnic group; African Americans were more affected by negative emotions and caregiving responsibilities, while whites faced issues related to trust in physicians and perceived treatment ineffectiveness, suggesting that tailored interventions are needed for each group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to treatment adherence among African American and white women with systemic lupus erythematosus. Mosley-Williams, A., Lumley, MA., Gillis, M., et al.[2022]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06458075

Intervention to Improve Communication and Medication ... CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE). The ...

2. jrheum.org jrheum.org/content/early/2024/05/26/jrheum.2024-0071

Implementation of a clinician-led medication adherence ... Adherence discussions took on average 3.8 minutes, and 44% of patients had ≥20% increase in PDC post-intervention. In structured interviews, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4853651/

Patient-Reported Outcomes in Systemic Lupus ... Successful management of complex conditions such as systemic lupus erythematosus, SLE, and comorbid conditions benefit significantly from patient-reported ...

4. the-rheumatologist.org the-rheumatologist.org/article/new-quality-measures-aim-to-address-gaps-inequities-in-lupus-care/?singlepage=1

New Quality Measures Aim to Address Gaps & Inequities ... The ACR has been leading a project to reduce inequities in symptom recognition, care and disease management of SLE.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875561/

Clinical trial outcomes for SLE: what we have and what we need Damage can lead to permanent impairment and disability but is complex to assess in SLE trials due to the generally short duration of follow-up.

6. nature.com nature.com/articles/s41392-025-02168-0

Systemic lupus erythematosus: updated insights on the ... Besides, SLE-related factors such as disease activity and medication use have been reported to be risky for developing low bone mineral density.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0049017224001471

Modelling long-term outcomes for patients with systemic ... This study sought to develop natural history models to identify predictors of long-term outcomes with current SoC SLE treatment.

8. roche.com roche.com/investors/updates/inv-update-2025-11-03

Positive phase III data for Roche's Gazyva/Gazyvaro show ... The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI ...

9. lupus.bmj.com lupus.bmj.com/content/11/1/e001114

Clinical trial outcomes for SLE: what we have and what ... Damage can lead to permanent impairment and disability but is complex to assess in SLE trials due to the generally short duration of follow-up.