Use of the Multidimensional Health Assessment Questionnaire (MDHAQ/RAPID3) in Follow-up of Patients With Rheumatoid Arthritis by Telemedicine: A Non-Inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Non-inferiority of telehealth monitoring according to differences in means of CDAI
研究概览
简要总结
The purpose of this Non-inferiority Randomized Clinical Trial is to evaluate the effectiveness of RHEUPP App during telehealth follow-up in a population of Rheumatoid Arthritis patients from a Tertiary Rheumatology Service in South Brazil.
The main question[s] it aims to answer are:
• Using RHEUPP App in telemedicine is not inferior to usual care in terms of means obtained by CDAI.
Participants will be stratified by CDAI and then randomized 1:1 for intervention or control group. They will be evaluated at study starting, in 3 and 6 months, an extended evaluation after 12 months of recruitment is predicted.
Researchers will compare intervention and control group to detect differences between usual care and Telehealth follow-up and determine if the last is not less effective in our study population of rheumatic patients.
详细描述
Participants with access to digital media will be sent a weblink for accessing the study's electronic questionnaires by electronic message or email, with a maximum interval of one week before or after your in-person consultation, according to the research participant's preference. A tablet will be made available to patients who choose to carry out the survey on the day of their in-person assessment. Participants randomized to the intervention group will receive guidance regarding the download or access to the RHEUPP application, with a period of training and adaptation to the tool, to be carried out by Social Monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients (18y or older)
- •Rheumatoid Arthritis according to the 2010 EULAR/ACR criteria
- •Access to digital media (electronic messages, e-mail)
排除标准
- •Other rheumatological diseases (except Sjögren's Syndrome)
- •Inability to understand the instrument in general or assistance from third parties (family member or caregiver) in carrying out the questionnaire at a disadvantage
- •Incomplete information in data collection
- •Patients with changes in their treatment in the last 4 weeks or treatment change plan at recruitment to the study.
结局指标
主要结局
Non-inferiority of telehealth monitoring according to differences in means of CDAI
时间窗: From study start to 26 weeks (extended evaluation at 52 weeks)
Non-inferiority margin of -0.6 u.m defined based on a 50% of Good EULAR Response criteria (with a 10% increase for possible losses and refusals, this number should be 88). The calculation considered a non-inferiority margin of -6 u.m., a power of 80%, level of significance of 5%, difference of 0 u.m between the means and standard deviation of 10.6 u.m. (data Non-inferiority margin of -6 u.m defined based on a 50% of Good EULAR Response criteria
次要结局
- Non-inferiority of telehealth monitoring according to differences in means of DAS28(From study start to 26 weeks (extended evaluation at 52 weeks))
- Percentage of participants achieving remission criteria by DAS28, CDAI and SDAI(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline to HAQ and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Differences in means of SDAI between groups(From study start to 26 weeks (extended evaluation at 52 weeks))
- Response rate to ACR70(From study start to 26 weeks (extended evaluation at 52 weeks))
- Response rate to ACR20(From study start to 26 weeks (extended evaluation at 52 weeks))
- Changes in baseline for DAS28(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline to System Usability Scale (SUS) and its correlations(From study start to 26 weeks (extended evaluation at 52 weeks))
- Changes in baseline for CDAI(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline in RAPID3 and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline to uMARS and its correlations(From study start to 26 weeks (extended evaluation at 52 weeks))
- Percentage of participants achieving Boolean remission in the ACR/EULAR criteria(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline in detection of Flare by RAPID3(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Assessment of FIQ and FSQ scores and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Response rate to ACR50(From study start to 26 weeks (extended evaluation at 52 weeks))
- Percentage of participants achieving remission criteria by ACR/EULAR(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline to ASES-8 Questionnaire and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Changes in baseline for SDAI(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Percentage of participants dropping-out from study(From study start to 26 weeks (extended evaluation at 52 weeks))
- Change from baseline in Physician and Patient Global Assessment (PGA-VAS)(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Change from baseline in MDHAQ and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Percentage of participants in the EULAR response criteria for "Good response" and "Moderate Response"(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Correlations with clinical assessment and other scores with Flare detection by the score RAPID3(From study start to 26 weeks (extended evaluation at 52 weeks))
- Assessment of FACIT and its correlations(From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks))
- Cost-effectiveness evaluation(From study start to 26 weeks (extended evaluation at 52 weeks))