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 (SAFO)

Smart Aneurysm FOllow-up

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: GetReady digital platform

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L index score at 12 months	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.	Baseline and 12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L visual analogue scale score at 12 months	Overall self-rated health status assessed using the EQ-5D-5L Visual Analogue Scale (VAS). The EQ VAS records the participant's self-rated health on a scale from 0 to 100, with higher scores indicating better perceived health.	12 months after enrollment
PPE-15 total score at hospital discharge or post-procedure assessment	Patient experience assessed using the Picker Patient Experience Questionnaire (PPE-15) in participants who undergo an intervention and hospital admission. The PPE-15 evaluates patient experience during inpatient care. The outcome will be reported as the PPE-15 total score.	30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure
Net Promoter Score reported by patients for the digital platform	Patient Net Promoter Score (NPS) for the use of the digital platform, calculated as the percentage of promoters (score 9-10) minus the percentage of detractors (score 0-6). Scores range from -100 to +100, with higher scores indicating greater likelihood to recommend the platform.	12 months after enrollment
Percentage of scheduled PROM and PREM questionnaires completed through the digital platform	Adherence to digital follow-up measured as the percentage of scheduled patient-reported outcome and patient-reported experience questionnaires completed through the digital platform during follow-up.	Up to 12 months after enrollment
Percentage of participants remaining active on the digital platform at 12 months	Retention in digital follow-up measured as the percentage of enrolled participants who remain active users of 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	Utilization of in-person follow-up will be assessed as the ratio of the total number of in-person visits (first visits plus follow-up visits within 90 days after treatment) divided by the number of therapeutic procedures performed during the same period.	Within 90 days after therapeutic procedure
Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention	Readmission will be assessed as the number of participants who, within 30 days after discharge following aneurysm-related therapeutic intervention, have a hospitalization episode associated with diagnosis code of intracranial aneurysm.	Within 30 days after discharge following therapeutic intervention
Number of participants with post-procedural complications within 30 days after discharge following therapeutic intervention	Post-procedural complications will be assessed as the number of participants with readmission within 30 days after discharge and/or documentation of clinically relevant complications during follow-up, including subarachnoid hemorrhage when present.	Within 30 days after discharge following therapeutic intervention
Mean length of hospital stay in days per therapeutic procedure	Length of stay will be calculated as the sum of hospital stay duration in hours divided by 24, and then divided by the total number of therapeutic procedures performed during the same period. The outcome will be reported as mean length of stay in days per therapeutic procedure.	During the study period, up to January 2029

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: IIBSP-SAF-2025-114; GA 101172997 (Other Grant/Funding Number: HORIZON-IHI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No