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Behavioral Intervention
Education and Navigation Program for Lupus (LEAP Trial)
N/A
Recruiting
Led By David H Chae, Sc.D., M.A.
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Living with systemic lupus erythematosus (SLE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
LEAP Trial Summary
This trial tests if an educational program can increase COVID testing/vaccination among people with lupus and their social networks.
Who is the study for?
This trial is for adults over 18 living with systemic lupus erythematosus (SLE) in metropolitan Birmingham, Alabama. Participants must be able to speak and understand English. Those without a confirmed SLE diagnosis, under 18, or living outside the specified area cannot join.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of two approaches: one that provides only education about COVID-19 testing and vaccination, and another that includes navigation assistance to help people with SLE get tested or vaccinated against COVID-19.See study design
What are the potential side effects?
Since this trial focuses on education and navigation interventions rather than medical treatments, there are no direct side effects associated with drugs or medical procedures.
LEAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have systemic lupus erythematosus (SLE).
LEAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of COVID testing
Incidence of COVID-19 Vaccination
LEAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NavigationExperimental Treatment1 Intervention
COVID education for people with lupus and tailored guidance in vaccination and testing for COVID and making appointments.
Group II: EducationActive Control1 Intervention
COVID education for people with lupus.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navigation
2013
Completed Phase 4
~3660
Find a Location
Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
43,701 Total Patients Enrolled
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,002 Total Patients Enrolled
Xavier University of Louisiana.OTHER
6 Previous Clinical Trials
2,328 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have systemic lupus erythematosus (SLE).
Research Study Groups:
This trial has the following groups:- Group 1: Navigation
- Group 2: Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more participants being taken into this research trial?
"That is accurate. According to information provided on clinicaltrials.gov, this medical trial began recruiting participants on February 1st 2023 and will continue until 800 patients are recruited from a single research centre."
Answered by AI
What is the current enrollment for this research project?
"Right. Data hosted on clinicaltrials.gov confirms that this study, which was initially posted in February of 2023, is currently recruiting participants. In total, 800 people must be enrolled at one location."
Answered by AI
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