Virtual Reality Assisted Patient Empowerment: Diagnose ATTR-Amyloidosis And Start Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time-to-Event
研究概览
简要总结
ATTR amyloidosis is a serious condition with significant morbidity and mortality. In Germany, there are numerous unreported cases of untreated patients, and diagnosing and initiating treatment often requires multiple specialized tests. To address this, a study is being conducted to determine if virtual reality (VR)-based patient education can improve diagnosis rates, treatment initiation, and medication adherence compared to standard education methods.
详细描述
Tafamidis is effective in reducing mortality and hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), and adherence to the drug is generally high. However, the main challenge lies in timely diagnosis and initiation of therapy. Virtual reality (VR) offers an immersive educational tool that surpasses conventional methods like brochures and videos, with patients preferring VR glasses. By preparing patients through VR, they can engage in informed conversations with physicians, understand the diagnostic process better, and be motivated to initiate therapy promptly. VR empowers patients and saves valuable time for physicians, and it has been well-received even among older cardiovascular patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who present themselves for assessment of an unclear septal thickening with suspicion of cardiac amyloidosis.
排除标准
- •< 18 years
- •Active Medication with tafamidis
- •Cardiovascular Disease
- •highly impaired vision or hearing
- •advanced dementia syndrome
- •insufficient language skills
研究组 & 干预措施
intervention
In this intervention, VR glasses with an information module are utilized, lasting approximately 25 minutes. This intervention takes place in the waiting room prior to the actual physician-patient conversation and complements the usual care provided through brochures
干预措施: Intervention (Device)
Control Group
Usual Care
结局指标
主要结局
Time-to-Event
时间窗: up to 180 days
Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. \[time frame: xx days\] 1. Time-to-Event \[days\] Count days after first use of VR until the final diagnosis or prescription of tafamidis is given. \[time frame: xx days\] Count days after first use of VR until the final diagnosis or prescription of tafamidis is given
次要结局
- health literacy: Baseline(1 hour before patient-physician talk after enrollment)
- Rate of patients who died or were re-hospitalized during the long term follow up(after 6 and 12 months after enrollment)
- Simulator Sickness Questionnaire (SSQ)(immediately after Virtual Reality (VR-) Education)
- Duration patient-physician talk(up to 30 minutes)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(after 6 months after enrollment)
- Health literacy baseline: Long term(up to 180 days after patient-physician talk)
- Drug-Adherence to tafamidis(after 6 months after enrollment)
- Health literacy: after the first patient-physician-talk(1 hour after patient-physician talk])