Communication and Medication Adherence Intervention for Lupus
(CO-LEAD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Must be taking: SLE medications
Must not be taking: Only corticosteroids
Disqualifiers: Non-English speakers, minors, others
No Placebo Group
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.
12345How 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.
23678Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Control clinicians will continue usual care.
Group II: CO-LEADActive Control1 Intervention
CO-LEAD clinicians will receive training in the intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Medication decision-making and adherence in lupus: patient-physician discordance and the impact of previous 'adverse medical experiences'. [2022]Medication adherence is critical in the successful management of lupus. There is very limited existing literature on reasons why non-adherence is not reported. This study explores the impact of current and previous medical experiences on patient satisfaction, adherence and reporting of non-adherence.
How Can We Enhance Adherence to Medications in Patients with Systemic Lupus Erythematosus? Results from a Qualitative Study. [2022]Medication non-adherence is common among patients with systemic lupus erythematosus (SLE) and may lead to poor clinical outcomes. Our aim was to identify influenceable contributors to medication non-adherence and suggest interventions that could increase adherence. Patients with SLE from two Swedish tertiary referral centres (n = 205) participated in a survey assessing self-reported adherence to medications. Responses were used to select patients for qualitative interviews (n = 15). Verbatim interview transcripts were analysed by two researchers using content analysis methodology. The median age of the interviewees was 32 years, 87% were women, and their median SLE duration was nine years. Reasons for non-adherence were complex and multifaceted; we categorised them thematically into (i) patient-related (e.g., unintentional non-adherence due to forgetfulness or intentional non-adherence due to disbelief in medications); (ii) healthcare-related (e.g., untrustworthy relationship with the treating physician, authority fear, and poor information about the prescribed medications or the disease); (iii) medication-related (e.g., fear of side-effects); and (iv) disease-related reasons (e.g., lacking acceptance of a chronic illness or perceived disease quiescence). Interventions identified that healthcare could implement to improve patient adherence to medications included (i) increased communication between healthcare professionals and patients; (ii) patient education; (iii) accessible healthcare, preferably with the same personnel; (iv) well-coordinated transition from paediatric to adult care; (v) regularity in addressing adherence to medications; (vi) psychological support; and (vii) involvement of family members or people who are close to the patient.
Patient and healthcare team recommended medication adherence strategies for hydroxychloroquine: results of a qualitative study informing intervention development. [2022]Patients identified as black and from disadvantaged backgrounds have a twofold higher hydroxychloroquine (HCQ) non-adherence, which contributes to worse lupus outcomes and disparities. Yet, most adherence interventions lack tailored strategies for racially and socioeconomically diverse patients who face unique challenges with HCQ. We aimed to examine a broadly representative group of patients with SLE and physician perspectives on HCQ adherence and adherence strategies to redesign an adherence intervention.
Measuring therapeutic adherence in systemic lupus erythematosus with electronic monitoring. [2022]We used an electronic monitoring system to quantify adherence to prescribed oral therapies by patients with systemic lupus erythematosus (SLE).
Association of Hurried Communication and Low Patient Self-Efficacy With Persistent Nonadherence to Lupus Medications. [2023]Medication nonadherence is common among patients with systemic lupus erythematosus (SLE), and adherence often fluctuates with time. Underrepresented racial minorities have disproportionately lower rates of medication adherence and more severe SLE manifestations. We aimed to identify modifiable factors associated with persistent medication nonadherence.
Increased Education is Associated with Decreased Compliance in an Urban Multi-Ethnic Lupus Cohort. [2020]To investigate the factors associated with medication compliance in a multi-ethnic population of patients with systemic lupus erythematosus in an urban community.
Pilot Intervention to Improve Medication Adherence Among Patients With Systemic Lupus Erythematosus Using Pharmacy Refill Data. [2023]Despite high rates of medication nonadherence among patients with systemic lupus erythematosus (SLE), effective interventions to improve adherence in SLE are limited. We aimed to assess the feasibility of a pilot intervention and explore its effect on adherence.
Barriers to treatment adherence among African American and white women with systemic lupus erythematosus. [2022]To determine whether African Americans with systemic lupus erythematosus (SLE) have poorer treatment adherence than whites, and to determine ethnic group differences in barriers to adherence, and how barriers affect adherence.