Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
研究概览
简要总结
This prospective, multicenter, controlled real-world quality management study explores the acceptance and utility of two measures discussed in the context of the German Digital Act (DigiG) for the digital health application (DiGA) Axia: a 14-day trial period and an application-related outcome measurement (AbEM). Patients with axial spondyloarthritis in Axia's indication area who are eligible for prescription in routine care will receive one of two onboarding brochure versions in a 1:1 allocation: either the standard access procedure or immediate 14-day trial access until the health insurance activation code arrives. The manufacturer will analyze aggregated anonymized data to compare voucher redemption and app activation frequencies between groups and to assess acceptance and return rates of a voluntary five-item AbEM questionnaire at weeks 6 and 12. Secondary analyses will descriptively evaluate AbEM results and anonymized usage data.
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 (Care Provider)
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
- •Willingness to use Axia.
- •Axia indication area.
- •Willingness to activate via onboarding brochure.
排除标准
- •Absence of the inclusion criteria
研究组 & 干预措施
Standard procedure
干预措施: Standard procedure (Other)
Immediate app-use by a test phase
干预措施: Test-phase with immediate access (Device)
结局指标
主要结局
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
时间窗: 12 weeks
Successful app activation is defined as successful redemption of the activation code by the participant. The outcome measure is the percentage of participants with successful app activation from baseline through week 12.
次要结局
- Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)(6 and 12 weeks)
- Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire(6 and 12 weeks)
- Exploratory analysis of anonymized usage data.(12 weeks)
研究者
Patrick-Pascal Strunz
PD. Dr. med.
Wuerzburg University Hospital