DRKS00040872进行中（未招募）不适用
Does Augmented Reality Improve Disease Understanding and Outcomes in Psoriatic Arthritis? - ARISE-PSA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 —（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of psoriatic arthritis according to the CASPAR classification criteria
- •Active disease (DAPSA >4)
- •Current treatment with self-administered medication (e.g. oral or subcutaneous) or planned initiation or switch to such treatment based on clinical indication
- •At least one and no more than five previous DMARD therapies
- •Self-rated disease-related knowledge of moderately informed or worse
- •Ability to complete study questionnaires independently
- •Sufficient German language skills
- •Written informed consent
排除标准
- •Current or planned intravenous antirheumatic therapy
- •Other inflammatory rheumatic systemic diseases likely to affect study outcomes
- •Severe cognitive impairment or relevant psychiatric disorders
- •Neurological disorders or contraindications to Augmented Reality applications (e.g. photosensitive epilepsy)
- •Acute severe comorbidities
- •Participation in another interventional clinical trial
- •Unwillingness or inability to comply with the study protocol
研究组 & 干预措施
Group 1: Intervention group (Augmented Reality-assisted patient education): Following screening, written informed consent and baseline assessments, participants are randomized in a 1:1 ratio. Participants allocated to this study arm receive a single structured 20-minute patient education session on psoriatic arthritis using an Augmented Reality application. The education is delivered by trained medical staff according to a standardized educational protocol and covers disease characteristics, pathophysiology, structural changes, and the principles and goals of medical treatment. Routine medical care remains unchanged throughout the study. Follow-up assessments are performed 1 hour and 4, 12, and 24 weeks after the intervention.
干预措施: Group 1: Intervention group (Augmented Reality-assisted patient education): Following screening, written informed consent and baseline assessments, participants are randomized in a 1:1 ratio. Participants allocated to this study arm receive a single structured 20-minute patient education session on psoriatic arthritis using an Augmented Reality application. The education is delivered by trained medical staff according to a standardized educational protocol and covers disease characteristics, pathophysiology, structural changes, and the principles and goals of medical treatment. Routine medical care remains unchanged throughout the study. Follow-up assessments are performed 1 hour and 4, 12, and 24 weeks after the intervention.
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