Feasibility and Performance of a Structured Video Telemedicine Program in Patients With Systemic Lupus Erythematous

NCT07840573 | Completed

• 1 other identifier: H-53228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine the feasibility, effectiveness and safety of a structured video telemedicine program for the treatment of patients with systemic lupus erythematous in a under-resourced clinic. Patients with SLE who are interested in participating, with low disease activity, will be randomized to video or in person clinic visit for their next clinical visit. They will cross over to the other group for their follow up appointment in 3 months.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; telemedicine

Outcome Measures

Primary Outcomes (2)

• Telehealth Usability Questionaire (TUQ), Total Overall Score

  Telehealth Usability Questionaire (TUQ), Total Overall Score is derived by adding up the liker scale response (1 = Strongly disagree, 7 = Stronly agree) for each of the 21 questions and dividing by 21 to get a total overall score from 1-7 (1 = Strongly disagree, 7 = Stronly agree)

  3 and 6 months

• No show rate

  The percent of visits where the patient did not show for the appointment

  3 and 6 months

Secondary Outcomes (6)

• laboratory utilization

  3 and 6 months

• Disease activity as measured by Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

  3 and 6 months

• Physician global assessment

  3 and 6 months

• Patient global assessment

  3 and 6 months

• Lupus flare rate

  3 and 6 months

Study Arms (2)

Group 1 (telemedicine at Month 3 → in-person at Month 6)

EXPERIMENTAL

Patients randomized to group 1 will have a telemedicine visit in 3 months followed by an in person visit in 6 months

Behavioral: Structured video telemedicine visit

Group 2 (in-person → telemedicine)

ACTIVE COMPARATOR

Patients randomized to group 1 will have an in person visit in 3 months followed by a telemedicine visit in 6 months

Behavioral: Structured video telemedicine visit

Interventions

Structured video telemedicine visit BEHAVIORAL

Patients will be randomized to a 3 month follow up visit of video or in person, then cross over at 6 months to the other arm

Group 1 (telemedicine at Month 3 → in-person at Month 6); Group 2 (in-person → telemedicine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of systemic lupus erythematous (SLE) by the 2019 ACR criteria
• Age equal to or greater than 18 years
• Low disease activity as defined by SLE Disease Activity Index (SLEDAI) score ≤ 4
• Patients taking less than or equal to prednisone 5 mg daily
• Patients can speak English or Spanish

You may not qualify if:

• \- Patients with moderate to high disease activity as defined by a SLEDAI score of more than 5.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• American College of Rheumatology Research and Education Foundation: collaborator

Study Sites (1)

Baylor College of Medicine, Harris Health Hosptial District - Smith Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Behavioral: Structured video telemedicine visit

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: September 25, 2026
• Study Start: April 1, 2024
• Primary Completion: June 10, 2026
• Study Completion: June 10, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)