Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial
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
- 否
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
Anne Bull Haaversen
Co-principal Investigator
Martina Hansen's Hospital
