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| ID | Type | Description | Link |
|---|---|---|---|
| GA 101172997 | Other Grant/Funding Number | HORIZON-IHI |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after enrollment |
| PPE-15 total score at hospital discharge or post-procedure assessment |
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Inclusion Criteria:
Exclusion Criteria:
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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