An interventional study of Home hospitalization in Stroke (CVA) or TIA and Stroke Recurrence, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Supportive care
In this project, we aim to validate a Home Hospitalization plan for patients with TIA or minor stroke. Our hypothesis is that our Multimodal Home Hospitalization program (NORAHOME) for patients with TIA and minor stroke is safe, reduces the complications associated with conventional hospitalization, and is more efficient than Standard Clinical Practice. To conduct the study, we require the voluntary participation of patients with TIA and minor strokes.
Background: The risk of stroke recurrence is higher in patients who have previously experienced a minor or self-limited event. It is necessary to develop strategies that allow rapid evaluation of these patients and the early initiation of preventive treatment. However, early etiological study of these patients usually requires admission to an Acute Stroke Unit, which entails the cost of a potentially avoidable hospital stay, the inherent risks of hospitalization in fragile patients, and a suboptimal experience for both patients and their families. As an alternative to admission, these patients are discharged from the emergency department to be evaluated early on an outpatient basis in "TIA clinics," with suboptimal clinical and hemodynamic monitoring that does not effectively reduce the risk of early recurrence.
Hypothesis: Our hypothesis is that our Multimodal Home Hospitalization program (NORAHOME) for patients with TIA and minor stroke is safe, reduces the complications inherent to conventional hospitalization, and is more efficient than Standard Clinical Practice.
Objectives:
Primary: To validate that our Home Hospitalization program for patients with TIA or minor stroke (NORAHOME) is an efficient strategy compared to Standard Clinical Practice while maintaining the same level of patient safety.
Primary efficacy objective: Reduce the risk of early recurrence and hospital readmission compared to standard clinical practice.
Primary safety objective: No increase in the number of complications in patients with TIA/minor stroke (falls, recurrences, infections) compared to standard clinical practice.
Secondary:
Reduce direct hospital costs.
Improve patient-reported health outcomes (PROMS) and their experience with the healthcare system (PREMS) compared to standard clinical practice.
Reduce complications inherent to hospital admission (delirium, nosocomial infections, falls).
Improve knowledge about stroke and key secondary prevention recommendations after the acute stroke phase.
Improve control of vascular risk factors and treatment adherence after the acute stroke phase.
Improve assessment of basic (ADL) and instrumental activities of daily living (IADL) compared to standard clinical practice.
Evaluate point-of-care etiological diagnostic studies, including focused echocardiography and multimodal remote cardiac monitoring.
Methodology: This is a single-center, prospective, randomized study of consecutive patients with TIA and minor stroke admitted to the Emergency Department. After signing informed consent, patients will be consecutively randomized to the treatment group (NORAHOME) or the control group (Standard Clinical Practice). After completing a 3-month follow-up period, a comparative statistical analysis between the treatment and control groups will be conducted
Relevance: All guidelines recommend early management of TIA and minor stroke, but there is no consensus on the best care model. It is therefore necessary to develop fast-track pathways to dedicated facilities for evaluation, diagnosis, risk assessment of recurrence, and management of patients with TIA and minor stroke. If the study results confirm the hypothesis, in addition to reducing healthcare costs and relieving pressure on Stroke Units-given the increasing number of patients affected by this condition-it would demonstrate an improvement in the health and quality of life of these patients. The comprehensive care plan and technological development could also allow the inclusion of patients with more severe impairment, through the administration of telerehabilitation treatments (physiotherapy, speech therapy, and occupational therapy), ensuring proper follow-up and facilitating the patient's return to daily life.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 250 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients presenting to the Emergency Department with symptoms of (complete recovery of neurological deficits within \<24 hours) or minor stroke (NIHSS ≤ 5)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized to be hospitalized at home
Other: Home hospitalization
Randomized to conventional hospitalization
patients randomized to the treatment group (NORAHOME) to validate that our Home Hospitalization program for patients with TIA or minor stroke
Also known as: Norahome, Treatment group
Primary efficacy objective
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Time frame: 3months
Primary efficacy objective
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Time frame: 3 months
Primary safety objective
Change in the number of complications (falls, recurrences, infections) in patients with TIA/minor stroke compared to standard clinical practice.
Time frame: 3months
Effectiveness
Change in direct hospital costs compared to standard clinical practice.
Time frame: 15days
Security
Change in the incidence of complications associated with hospital admission (delirium, nosocomial infections, falls).
Time frame: 15 days
Patient reported outcomes
Change in patient-reported health outcomes (PROMs) and patient experience measures (PREMs) compared to standard clinical practice
Time frame: 3months
Patient information
Change in patient knowledge about stroke and key secondary prevention recommendations after the acute stroke phase.
Time frame: 3months
Plan to share: No — The variables collected will come from the structured electronic medical record and from the server where NORA information is stored. Data from the structured electronic medical record and NORA are hosted on the hospital's servers. No data will be shared outside the hospital. Based on this information, a database will be created with coded datasets from the different data sources, using a common encrypted code across the datasets to replace any information that could identify individuals. These datasets will be hosted on a specific server at Vall d'Hebron University Hospital. The link between the code and the patient's identity will be handled with the highest level of protection on internal servers at Vall d'Hebron Hospital, accessible only to the Principal Investigator and co-investigators through a secure username and password.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 29 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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