Feasibility and Initial Performance of a Structured Video Telemedicine Program in Patients With Systemic Lupus Erythematous
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Telehealth Usability Questionaire (TUQ), Total Overall Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Patients with moderate to high disease activity as defined by a SLEDAI score of more than 5.
研究组 & 干预措施
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
干预措施: Structured video telemedicine visit (Behavioral)
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
干预措施: Structured video telemedicine visit (Behavioral)
结局指标
主要结局
Telehealth Usability Questionaire (TUQ), Total Overall Score
时间窗: 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
时间窗: 3 and 6 months
The percent of visits where the patient did not show for the appointment
次要结局
- 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)
- Acute care utilization(3 and 6 months)
研究者
Sandeep
Associate Professor
Baylor College of Medicine