A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- - Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
研究概览
简要总结
The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.
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
- None
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
- •Age ≥ 18 years.
- •Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9].
- •Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit.
- •Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP.
排除标准
- •Current or previous use of ArthritisPower™ by the patient.
- •Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer)
- •Inability or unwillingness to participate with using the ArthritisPower™ app for this study
研究组 & 干预措施
Control Arm
Standard of care
Intervention Arm
Mobile Health App
干预措施: Mobile Health App (Behavioral)
结局指标
主要结局
- Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1).
时间窗: 24 months
次要结局
未报告次要终点
研究者
John M. Davis, III
Principal Investigator
Mayo Clinic