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临床试验/NCT02822521
NCT02822521已完成不适用

A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
2
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

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

结局指标

主要结局

Treatment Satisfaction Questionnaire for Medication (TSQM)

时间窗: 6 months

Clinical Disease Activity Index (CDAI)

时间窗: 6 months

Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel H. Solomon, M.D.,MPH

Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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