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临床试验/NCT04536844
NCT04536844Unknown不适用

Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial

Martina Hansen's Hospital2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
220
试验地点
2
主要终点
Number of patients suffering a flare

研究概览

简要总结

The main objective of the present project is to test the effect of a customized Patient-Reported-Outcome (PRO)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with RA

详细描述

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease with a high burden both for the patient and society. Outcomes for the individuals living with RA have been improved and the majority of RA patients are now in remission or low disease activity status. RA patients continue to be followed up by pre-scheduled visits, which may compromise accessibility for the sickest and thus, quality of care. The introduction of patient-initiated follow-up leads to a reduction in the use of outpatient clinic services without compromising outcomes. Self-monitoring and remote patient monitoring are facilitated by electronic innovative health tools. Among RA patients with low disease activity or remission, a Patient-Reported Outcome-based telehealth follow-up for tight control of disease activity in RA can achieve similar disease control as conventional outpatient follow-up and is likely to reduce the costs. Thus, the main objective of the present project is to test the effect of a customized PRO-based telehealth follow-up compared to a conventional prescheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in Norwegian RA patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, 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

入选标准

  • Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
  • Being in remission (RAPID 3 score <=3)
  • Able to use the electronic app
  • Able to give informed consent

排除标准

  • Severe cognitive failure

结局指标

主要结局

Number of patients suffering a flare

时间窗: 52 weeks

comparison of the number of patients suffering a flare in each group (Flare is defined as a routine assessment of patient index data 3 (RAPID3) score \>=3)

次要结局

  • Satisfaction rates(52 weeks)
  • Clinical disease activity index (CDAI)(52 weeks)

研究者

发起方
Martina Hansen's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Bull Haaversen

Co-principal Investigator

Martina Hansen's Hospital

研究点 (2)

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