Clinical, Organizational, and Care Impact of the GetReady Digital Platform as a Clinical Decision Support Tool in the Follow-up of Patients With Cerebral Aneurysm

Официальное название

Smart Aneurysm FOllow-up

Обзор

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.

Вмешательства

• Устройство GetReady digital platform
  CE-marked digital platform used to support follow-up of patients with cerebral aneurysm through structured collection and visualization of clinical, radiological, and patient-reported data during routine care.

Первичные конечные точки

• EQ-5D-5L index score at 12 months [Срок оценки: Baseline and 12 months after enrollment]

Вторичные конечные точки (9)

• EQ-5D-5L visual analogue scale score at 12 months [Срок оценки: 12 months after enrollment]
• PPE-15 total score at hospital discharge or post-procedure assessment [Срок оценки: 30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure]
• Net Promoter Score reported by patients for the digital platform [Срок оценки: 12 months after enrollment]
• Percentage of scheduled PROM and PREM questionnaires completed through the digital platform [Срок оценки: Up to 12 months after enrollment]
• Percentage of participants remaining active on the digital platform at 12 months [Срок оценки: 12 months after enrollment]
• Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment [Срок оценки: Within 90 days after therapeutic procedure]
• Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention [Срок оценки: Within 30 days after discharge following therapeutic intervention]
• Number of participants with post-procedural complications within 30 days after discharge following therapeutic intervention [Срок оценки: Within 30 days after discharge following therapeutic intervention]
• Mean length of hospital stay in days per therapeutic procedure [Срок оценки: During the study period, up to January 2029]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patients treated with surgical clipping
• Absence of informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07569562 · IIBSP-SAF-2025-114 · GA 101172997

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗