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Not yet recruiting NCT07569562

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

No phase Interventional Intracranial Aneurysms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GetReady digital platform.
Who it may be relevant to
Registry conditions: Intracranial Aneurysms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Smart Aneurysm FOllow-up

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • EQ-5D-5L index score at 12 months [Time frame: Baseline and 12 months after enrollment]
Secondary outcome measures (9)
  • EQ-5D-5L visual analogue scale score at 12 months [Time frame: 12 months after enrollment]
  • PPE-15 total score at hospital discharge or post-procedure assessment [Time frame: 30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure]
  • Net Promoter Score reported by patients for the digital platform [Time frame: 12 months after enrollment]
  • Percentage of scheduled PROM and PREM questionnaires completed through the digital platform [Time frame: Up to 12 months after enrollment]
  • Percentage of participants remaining active on the digital platform at 12 months [Time frame: 12 months after enrollment]
  • Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment [Time frame: Within 90 days after therapeutic procedure]
  • Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention [Time frame: Within 30 days after discharge following therapeutic intervention]
  • Number of participants with post-procedural complications within 30 days after discharge following therapeutic intervention [Time frame: Within 30 days after discharge following therapeutic intervention]
  • Mean length of hospital stay in days per therapeutic procedure [Time frame: During the study period, up to January 2029]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Patients treated with surgical clipping
  • Absence of informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗