Intracranial AneurysmsSAFONCT07569562
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
A study testing GetReady digital platform in people with Intracranial Aneurysms, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- GetReady digital platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients treated with surgical clipping
- Absence of informed consent
About this study
Official title: 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.
- Conditions
- Intracranial Aneurysms
- Being tested
- GetReady digital platform
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GetReady digital platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| GetReady Digital Follow-up | Experimental | 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. Receives: Device: GetReady digital platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months after enrollment
Secondary outcomes (9)
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.
Measured: 12 months after enrollment
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.
Measured: 30 days after hospital discharge - post diagnostic procedure and post-therapeutic procedure
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.
Measured: 12 months after enrollment
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.
Measured: Up to 12 months after enrollment
Percentage of participants remaining active on the digital platform at 12 months
Retention in digital follow-up measured as the percentage of enrolled participants who remain active users of the digital platform at 12 months.
Measured: 12 months after enrollment
Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment
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.
Measured: Within 90 days after therapeutic procedure
Number of participants readmitted within 30 days after discharge following aneurysm-related 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.
Measured: Within 30 days after discharge following therapeutic intervention
Number of participants with post-procedural complications 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.
Measured: Within 30 days after discharge following therapeutic intervention
Mean length of hospital stay in days per therapeutic procedure
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.
Measured: During the study period, up to January 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start18 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569562
- Sponsor's protocol ID
- IIBSP-SAF-2025-114
- Other IDs
- GA 101172997
- Acronym
- SAFO
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Aneurysm FOllow-up
- ClinicalTrials.gov ID
- NCT07569562
- Acronym / sponsor ID
- SAFO / IIBSP-SAF-2025-114
- Conditions
- Intracranial Aneurysms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GetReady Digital Follow-up | Experimental | Device: GetReady digital platformParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients treated with surgical clipping
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GetReady digital platformCE-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. | Device | GetReady Digital Follow-up |
Primary outcome
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.
9 secondary outcomes
EQ-5D-5L visual analogue scale score at 12 months
Time frame: 12 months after enrollment
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
Net Promoter Score reported by patients for the digital platform
Time frame: 12 months after enrollment
Percentage of scheduled PROM and PREM questionnaires completed through the digital platform
Time frame: Up to 12 months after enrollment
Percentage of participants remaining active on the digital platform at 12 months
Time frame: 12 months after enrollment
Mean number of in-person follow-up visits per therapeutic procedure within 90 days after treatment
Time frame: Within 90 days after therapeutic procedure
Number of participants readmitted within 30 days after discharge following aneurysm-related therapeutic intervention
Time frame: Within 30 days after discharge following therapeutic intervention
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
Mean length of hospital stay in days per therapeutic procedure
Time frame: During the study period, up to January 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GetReady digital platform in people with Intracranial Aneurysms, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L index score at 12 months (time frame: Baseline and 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.