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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients treated with surgical clipping

Absence of informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: GetReady Digital Follow-upExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and 12 months after enrollment

Secondary outcomes

1

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.

Time frame
12 months after enrollment
2

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.

Time frame
30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure
3

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.

Time frame
12 months after enrollment
4

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.

Time frame
Up to 12 months after enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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