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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment CO-LEAD for lupus?

Research suggests that improving communication between healthcare professionals and patients, along with patient education and psychological support, can enhance medication adherence in lupus patients. These components are likely part of the CO-LEAD treatment, which may help patients stick to their medication plans and improve their health outcomes. ^{1 2 3 4 5}

How is the CO-LEAD treatment for lupus different from other treatments?

The CO-LEAD treatment is unique because it focuses on improving communication between healthcare professionals and patients, enhancing patient education, and providing psychological support to increase medication adherence, which is a common issue in lupus management. ^{2 3 6 7 8}

Research Team

Kai Sun, MD

Principal Investigator

Duke University

Eligibility Criteria

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

I am under the care of a doctor.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Medication decision-making and adherence in lupus: patient-physician discordance and the impact of previous 'adverse medical experiences'. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

How Can We Enhance Adherence to Medications in Patients with Systemic Lupus Erythematosus? Results from a Qualitative Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patient and healthcare team recommended medication adherence strategies for hydroxychloroquine: results of a qualitative study informing intervention development. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Measuring therapeutic adherence in systemic lupus erythematosus with electronic monitoring. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Association of Hurried Communication and Low Patient Self-Efficacy With Persistent Nonadherence to Lupus Medications. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Increased Education is Associated with Decreased Compliance in an Urban Multi-Ethnic Lupus Cohort. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Barriers to treatment adherence among African American and white women with systemic lupus erythematosus. [2022]