Smart Aneurysm FOllow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- EQ-5D-5L index score at 12 months
研究概览
简要总结
This study evaluates the clinical, organizational, and care impact of the GetReady digital platform as a clinical decision support tool for the follow-up of patients with cerebral aneurysm. The platform integrates clinical, radiological, and patient-reported data, including PROMs and PREMs, and may incorporate home blood pressure monitoring. The study is an interventional implementation study with retrospective and prospective components. No additional medical, diagnostic, or therapeutic intervention is introduced, and all clinical decisions remain under routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of cerebral aneurysm
- •Access to one of the following: compatible mobile phone, computer, or tablet with internet access
- •Sufficient internet connection for use of the digital platform
- •When the patient cannot or does not wish to use the application directly, participation may occur through a designated caregiver or family member, after informed consent
排除标准
- •Patients treated with surgical clipping
- •Absence of informed consent
研究组 & 干预措施
GetReady Digital Follow-up
Participants with cerebral aneurysm enrolled in a digital follow-up pathway using the GetReady platform in addition to routine clinical care. The platform is used to collect and integrate clinical, radiological, and patient-reported data, including PROMs and PREMs, and may include home blood pressure monitoring when clinically indicated. The study does not introduce any additional medical, diagnostic, or therapeutic intervention, and all clinical decisions remain under routine practice.
干预措施: GetReady digital platform (Device)
结局指标
主要结局
EQ-5D-5L index score at 12 months
时间窗: Baseline and 12 months after enrollment
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The outcome will be reported as the EQ-5D-5L index score.
次要结局
- EQ-5D-5L visual analogue scale score at 12 months(12 months after enrollment)
- PPE-15 total score at hospital discharge or post-procedure assessment(30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure)
- Net Promoter Score reported by patients for the digital platform(12 months after enrollment)
- Percentage of scheduled PROM and PREM questionnaires completed through the digital platform(Up to 12 months after enrollment)
- Percentage of participants remaining active on the digital platform at 12 months(12 months after enrollment)
- Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment(Within 90 days after therapeutic procedure)
- Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention(Within 30 days after discharge following therapeutic intervention)
- Number of participants with post-procedural complications within 30 days after discharge following therapeutic intervention(Within 30 days after discharge following therapeutic intervention)
- Mean length of hospital stay in days per therapeutic procedure(During the study period, up to January 2029)