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

NCT07569562 | Not Yet Recruiting

• 2 other identifiers: IIBSP-SAF-2025-114GA 101172997
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

GetReady Digital Follow-up

EXPERIMENTAL

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

Interventions

GetReady digital platform DEVICE

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.

GetReady Digital Follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients treated with surgical clipping
• Absence of informed consent

Sponsors & Collaborators

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

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04