Lupus Education Alliance Program

NCT ID: NCT05243875

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-06-15

Brief Summary

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

Detailed Description

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

Conditions

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Systemic Lupus Erythematosus COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two-arm study in which participants are randomized to an experimental (education + navigation) or comparison (education only) group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

LEAP Education + Navigation

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

LEAP Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role lead

Responsible Party

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David Chae

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tulane University

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00073870

Identifier Type: -

Identifier Source: org_study_id

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