Lupus Education Alliance Program (LEAP)

July 30, 2025 updated by: David Chae, Tulane University
Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial of a COVID-19 behavioral and educational intervention for people with systemic lupus erythematosus (SLE).

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

18 years or older, ability to understand and speak English, diagnosis of SLE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education / Navigation
COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE; and (2) navigation, which involves individual tailoring of information about where and how to get tested, and where to get vaccinated, and when appropriate, guiding participants in scheduling testing and vaccination appointments.
Behavioral: LEAP Education + Navigation
COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE; and (2) navigation, which involves individual tailoring of information about where and how to get tested, and where to get vaccinated, and when appropriate, guiding participants in scheduling testing and vaccination appointments.
Active Comparator: Education Only
COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE.
Behavioral: LEAP Education
COVID education involving providing information about COVID for people with SLE and CDC recommendations for testing, testing options (e.g., pharmacies, doctors' offices, at-home), treatment in the event of a positive COVID result, and current recommendations around vaccination for those with SLE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of COVID testing
Time Frame: 3 months
Participant-reported COVID testing
3 months
Incidence of COVID-19 Vaccination
Time Frame: 3 months
Participant-reported COVID vaccination
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Collaborators

University of Alabama at Birmingham
Louisiana State University Health Sciences Center in New Orleans
Ochsner Health System

Investigators

  • Principal Investigator: David H Chae, Sc.D., M.A., Tulane University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 15, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00073870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available to researchers outside the study team after completion of the primary analyses. Data requests, including a list of variables and analytic plan, will be sent to the Project Coordinator and reviewed by the PI, who will approve or deny the data request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on LEAP Education + Navigation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe