Impact of a Hybrid Medical Care Model (Face-to-face Medical Visits Alternating With Video Medical Consultations) in the Rheumatoid Arthritis Patient-reported-outcomes Measures: A Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Rheumatoid arthritis patient´s disease activity
研究概览
简要总结
The COVID-19 outbreak has affected health care of patients with rheumatic diseases; telemedicine might help to assist patients.
The primary objective is to determine if a hybrid medical care model, which consists of alternating face-to-face medical visits and video medical consultations, is not inferior, in terms of the Patient Reported Outcomes measures (PROMs), to the face-to-face medical care model, among rheumatoid arthritis (RA) outpatients. We also aim to investigate if adherence to RA-related treatment (considered a surrogate of patient´s education) might be improved when patients are re-integrated to the health care system, irrespective of the health care model.
In Mexico, COVID-19 pandemic still uncontrolled. Our Institution provides health care to 1500 RA patients/year and up to August 2020, it is estimated that 500 RA patients might be affected, which is our target audience. Reinstalling institutional health care provision is challenging.
This a non-inferiority, cross-over study, with 2 intervention arms. Patients will be randomized to 1. Six months of usual medical care model, followed by 4 months of a control period, and 6 months of hybrid medical care model, or 2. Six months of hybrid medical care model, followed by 4 months of a control period, and 6 months of usual medical care model.
The following PROMs will be assessed at specific time points: disease activity/disease severity (RAPID-3), disability (HAQ-DI), quality of life (WHOQOL-BREF), patient satisfaction with the medical care model (questionnaire locally developed), patient´s adherence to medical care (missed scheduled visits) and patient´s adherence to RA-related treatment (the Compliance-Questionnaire).
详细描述
This a non-inferiority and cross-over study, with a planned follow-up of 16 months, with 2 intervention arms:
Intervention 1: Patients assigned to 6 months of usual medical care model, followed by 4 months control period, and finally 6 months of hybrid medical care model.
Intervention 2: Patients assigned to 6 months of hybrid medical care model, followed by 4 months control period and finally 6 months of usual medical care model.
Specific objectives are as follows:
Primary objectives
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
- •Patients with RA diagnosis according to their primary rheumatologist
- •With at least six months of follow-up (up to March 2020) at the outpatient clinic
- •Who agree to participate
排除标准
- •Patients lost to follow-up from the outpatient clinic before March 2020
- •Patients with no access to a mobile device during their study participation
- •Patients with severe cognitive, visual and hearing impairment
- •Patients on palliative care because of comorbid condition
结局指标
主要结局
Rheumatoid arthritis patient´s disease activity
时间窗: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
The disease activity measured by a RAPID-3 instrument
Rheumatoid arthritis patient´s quality of life
时间窗: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Quality of life measured by a WHOQOL-BREF instrument
Rheumatoid arthritis patient's disability
时间窗: During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models)
Disability measured by a HAQ-DI instrument
次要结局
- Satisfaction with medical care(During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models))
- Patient´s adherence to medical care(During the 16 months of follow up, the evaluations will be in each medical visits (in both medical care models))
研究者
Virginia Pascual Ramos
Rheumatologist
National Institute of Medical Sciences and Nutrition, Salvador Zubiran