Systemic Lupus ErythematosusNCT07840573
Feasibility and Performance of a Structured Video Telemedicine Program in Patients With Systemic Lupus Erythematous
A study testing Structured video telemedicine visit in people with Systemic Lupus Erythematosus, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Structured video telemedicine visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with moderate to high disease activity as defined by a SLEDAI score of more than 5.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine, Harris Health Hosptial District - Smith Clinic
Houston, Texas, 77030
About this study
Official title: Feasibility and Initial Performance of a Structured Video Telemedicine Program in Patients With Systemic Lupus Erythematous
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Structured video telemedicine visit
- Keywords
- Systemic Lupus Erythematosus, telemedicine
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured video telemedicine visitBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Structured video telemedicine visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 and 6 months
No show rate
The percent of visits where the patient did not show for the appointment
Measured: 3 and 6 months
Secondary outcomes (6)
laboratory utilization
The number of visits where the patient successfully obtained the required order labs for the monitoring of disease activity
Measured: 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)
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
Measured: 3 and 6 months
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
Measured: 3 and 6 months
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
Measured: 3 and 6 months
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
Measured: 3 and 6 months
Acute care utilization
Number of patients who required a visit to the urgent care of emergency room prior to the visit
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Apr 2024
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Behavioral: Structured video telemedicine visit
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation
- Responsible party
- Principal investigator, Sandeep, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840573
- Sponsor's protocol ID
- H-53228
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Initial Performance of a Structured Video Telemedicine Program in Patients With Systemic Lupus Erythematous
- ClinicalTrials.gov ID
- NCT07840573
- Acronym / sponsor ID
- H-53228
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- American College of Rheumatology Research and Education Foundation
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral: Structured video telemedicine visit
| Arm | Type | Receives |
|---|---|---|
| Group 1 (telemedicine at Month 3 → in-person at Month 6) | Experimental | Behavioral: Structured video telemedicine visitPatients randomized to group 1 will have a telemedicine visit in 3 months followed by an in person visit in 6 months |
| Group 2 (in-person → telemedicine) | Active comparator | Behavioral: Structured video telemedicine visitPatients randomized to group 1 will have an in person visit in 3 months followed by a telemedicine visit in 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with moderate to high disease activity as defined by a SLEDAI score of more than 5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured video telemedicine visitPatients 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 | Behavioural | Group 1 (telemedicine at Month 3 → in-person at Month 6), Group 2 (in-person → telemedicine) |
Primary outcome
Telehealth Usability Questionaire (TUQ), Total Overall Score
Time frame: 3 and 6 months
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)
No show rate
Time frame: 3 and 6 months
The percent of visits where the patient did not show for the appointment
6 secondary outcomes
laboratory utilization
Time frame: 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)
Time frame: 3 and 6 months
Physician global assessment
Time frame: 3 and 6 months
Patient global assessment
Time frame: 3 and 6 months
Lupus flare rate
Time frame: 3 and 6 months
Acute care utilization
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured video telemedicine visit in people with Systemic Lupus Erythematosus, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telehealth Usability Questionaire (TUQ), Total Overall Score (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.