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NCT Number: NCT07840573

Feasibility and 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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. No show rate

    Time frame: 3 and 6 months

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

Secondary outcomes

  1. laboratory utilization

    Time frame: 3 and 6 months

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

  2. 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

    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

  3. Physician global assessment

    Time frame: 3 and 6 months

    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

  4. Patient global assessment

    Time frame: 3 and 6 months

    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

  5. Lupus flare rate

    Time frame: 3 and 6 months

    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

  6. Acute care utilization

    Time frame: 3 and 6 months

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • American College of Rheumatology Research and Education Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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