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)
29 de abril de 2026 actualizado por: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EQ-5D-5L index score at 12 months
Periodo de tiempo: 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.
|
Baseline and 12 months after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EQ-5D-5L visual analogue scale score at 12 months
Periodo de tiempo: 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.
|
12 months after enrollment
|
|
PPE-15 total score at hospital discharge or post-procedure assessment
Periodo de tiempo: 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.
|
30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure
|
|
Net Promoter Score reported by patients for the digital platform
Periodo de tiempo: 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.
|
12 months after enrollment
|
|
Percentage of scheduled PROM and PREM questionnaires completed through the digital platform
Periodo de tiempo: 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.
|
Up to 12 months after enrollment
|
|
Percentage of participants remaining active on the digital platform at 12 months
Periodo de tiempo: 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.
|
12 months after enrollment
|
|
Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment
Periodo de tiempo: 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.
|
Within 90 days after therapeutic procedure
|
|
Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention
Periodo de tiempo: 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.
|
Within 30 days after discharge following therapeutic intervention
|
|
Number of participants with post-procedural complications within 30 days after discharge following therapeutic intervention
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
During the study period, up to January 2029
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
18 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
22 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIBSP-SAF-2025-114
- GA 101172997 (Otro número de subvención/financiamiento: HORIZON-IHI)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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