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Behavioral Intervention

Communication and Medication Adherence Intervention for Lupus (CO-LEAD Trial)

N/A
Recruiting
Led By Kai Sun, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during intervention period (up to 2 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve communication between patients and healthcare providers and help patients with lupus stick to their medication. The intervention includes teaching healthcare providers effective communication strategies and using a tool for patients to identify and

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on communication strategies rather than medication or medical procedures, there are no direct side effects associated with the interventions being studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during intervention period (up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during intervention period (up to 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of adherence discussions
Secondary study objectives
Change in SLE medication adherence
Quality of patient-clinician communication determined by audio recordings
Quality of patient-clinician communication determined by surveys

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,380 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
444 Previous Clinical Trials
1,413,028 Total Patients Enrolled
Kai Sun, MDPrincipal InvestigatorDuke University
~320 spots leftby Jul 2027
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