A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction Questionnaire for Medication (TSQM)
研究概览
简要总结
The overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (RA) disease activity between scheduled physician office visits. The population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (HCPs). The investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of RA disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Diagnosis of RA by a board-certified rheumatologist
- •Taking a DMARD (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine)
- •Own a smart phone with either an Android or iPhone operating system
- •Be English-speaking
排除标准
- •Patients who do not plan on receiving follow-up care at the Brigham and Women's Hospital Arthritis Center
研究组 & 干预措施
Mobile Application + Population Manager
This arm of the study will contain half the study population after randomization. The participants in this arm will receive the mobile application with daily questions after the first visit. A population manager will review patient-reported symptoms via a web-base dashboard and contact the subject based on pre-specified guidelines.
干预措施: Mobile Application (Other)
Mobile Application + Population Manager
This arm of the study will contain half the study population after randomization. The participants in this arm will receive the mobile application with daily questions after the first visit. A population manager will review patient-reported symptoms via a web-base dashboard and contact the subject based on pre-specified guidelines.
干预措施: Population Management System (Other)
No Mobile Application
This arm of the study will contain half the study population after randomization. The participants in this arm will not receive the mobile application after the first visit. Although participants will be provided with the contact information of a study staff member, there will be no active contact with the subject unless he/she initiates.
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication (TSQM)
时间窗: 6 months
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)
时间窗: 6 months
Clinical Disease Activity Index (CDAI)
时间窗: 6 months
次要结局
- Patient Activity Scale-II (PAS-II)(6 months)
- Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire(6 months)
研究者
Daniel H. Solomon, M.D.,MPH
Professor of Medicine
Brigham and Women's Hospital