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 april 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
200
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
EQ-5D-5L index score at 12 months
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
EQ-5D-5L visual analogue scale score at 12 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
18 mei 2026
Primaire voltooiing (Geschat)
31 december 2028
Studie voltooiing (Geschat)
31 december 2028
Studieregistratiedata
Eerst ingediend
22 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
29 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIBSP-SAF-2025-114
- GA 101172997 (Ander subsidie-/financieringsnummer: HORIZON-IHI)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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