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 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
EQ-5D-5L index score at 12 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
EQ-5D-5L visual analogue scale score at 12 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
18. mai 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
22. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIBSP-SAF-2025-114
- GA 101172997 (Annet stipend/finansieringsnummer: HORIZON-IHI)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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