ClinicalTrials.gg
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

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Apr 2024, registered Jul 2026).
Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 477 studies in Lupus Erythematosus, Systemic with a site in United States — 88 open to participants now, 128 under way, 28 of them phase 3. Lupus Erythematosus, Systemic · United States.

Enrollment
168th of 407
100 · median 70
Started
2024
with 32 others
No phase
65 of 477
6 open now
Registered
472nd of 477
by date

Among the 477 studies in Lupus Erythematosus, Systemic with a site in United States, this one is the 168th largest by enrollment of the 407 interventional ones that give a count, is one of 33 that started in 2024, is one of 65 with no phase, and was the 472nd registered.

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

Browse Lupus Erythematosus, Systemic studies →

Open to participants now

88 of the 477 studies in Lupus Erythematosus, Systemic with a site in United States are open now. Recruiting first, the newest first:

83 more — sign in →

All 88 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 477 studies in Lupus Erythematosus, Systemic with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • Systemic Lupus Erythematosus
  • telemedicine
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

05

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

06

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

07

Study locations

1 site
  • Baylor College of Medicine, Harris Health Hosptial District - Smith Clinic
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Jun 2026, 26 months.

Of 122 non-industry interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 26 months is above that.

Counting every sponsor, half of 129 studies reached it within 23 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2026
First posted
Sep 25, 2026
StartActual
Apr 1, 2024
Primary completionActual
Jun 10, 2026
CompletionActual
Jun 10, 2026
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840573
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 ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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