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CompletedNCT07840573Updated Sep 25, 2026

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

An interventional study of Structured video telemedicine visit in Systemic Lupus Erythematosus, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. Data obtained include patient's SLE disease activity, laboratory results, patient satisfaction and surveys of telemedicine.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Systemic Lupus Erythematosus
  • telemedicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

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

    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

  • Active comparator
    Group 2 (in-person → telemedicine)

    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

  • BehavioralStructured video telemedicine visit

    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

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 and 6 months

  2. No show rate

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

    Time frame: 3 and 6 months

Secondary outcomes

  1. laboratory utilization

    The number of visits where the patient successfully obtained the required order labs for the monitoring of disease activity

    Time frame: 3 and 6 months

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

    Lupus disease activity will be measured by the SELENA-SLEDAI disease activity assessment tool Scale is 0 to 105 0 = no activity of disease, 105 = maximal activity of disease

    Time frame: 3 and 6 months

  3. Physician global assessment

    The assessment of the patient's lupus disease activity based on liker scale as answered by the physician Scale 0-10 O = no disease activity as assesed by physician, 10 = maximal disease activity assessed by physician

    Time frame: 3 and 6 months

  4. Patient global assessment

    The assessment of the patient's lupus disease activity based on likert scale as answered by the patient Scale 0-10 O = no disease activity as assesed by patient, 10 = maximal disease activity assessed by patient

    Time frame: 3 and 6 months

  5. Lupus flare rate

    Assessment of flare of lupus activity based on Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI), comparing prior baseline assessment to the 3 and 6 month visit assessment

    Time frame: 3 and 6 months

  6. Acute care utilization

    Number of patients who required a visit to the urgent care of emergency room prior to the visit

    Time frame: 3 and 6 months

06

Study locations

1 site
  • Baylor College of Medicine, Harris Health Hosptial District - Smith Clinic
    Houston, Texas 77030, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07840573
Lead sponsor
Baylor College of Medicine
Collaborators
American College of Rheumatology Research and Education Foundation
Responsible party
Sandeep (Associate Professor, Baylor College of Medicine) — Principal investigator
First posted
Sep 25, 2026
Start date
Apr 1, 2024
Primary completion
Jun 10, 2026
Completion
Jun 10, 2026
Last update
Sep 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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