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NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. EQ-5D-5L index score at 12 months

    Time frame: Baseline and 12 months after enrollment

    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.

Secondary outcomes

  1. EQ-5D-5L visual analogue scale score at 12 months

    Time frame: 12 months after enrollment

    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.

  2. 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

    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.

  3. Net Promoter Score reported by patients for the digital platform

    Time frame: 12 months after enrollment

    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.

  4. Percentage of scheduled PROM and PREM questionnaires completed through the digital platform

    Time frame: Up to 12 months after enrollment

    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.

  5. Percentage of participants remaining active on the digital platform at 12 months

    Time frame: 12 months after enrollment

    Retention in digital follow-up measured as the percentage of enrolled participants who remain active users of the digital platform at 12 months.

  6. Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment

    Time frame: Within 90 days after therapeutic procedure

    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.

  7. Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention

    Time frame: Within 30 days after discharge following 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.

  8. 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

    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.

  9. Mean length of hospital stay in days per therapeutic procedure

    Time frame: During the study period, up to January 2029

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Smart Aneurysm FOllow-up

Acronym: SAFO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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