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)
2026년 4월 29일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EQ-5D-5L index score at 12 months
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EQ-5D-5L visual analogue scale score at 12 months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 18일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 4월 22일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 29일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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