NORA-HOME: An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks (NORAHOME)

NORA-HOME. Efficiency And Safety An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke (CVA) or TIA; Stroke Recurrence
• Intervention / Treatment: Other: Home hospitalization

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian Muchada Lopez, MD, PHD; Phone Number: 4448 +34 934893000; Email: mangeles.muchada@vallhebron.cat
• Study Contact Backup: Name: Marta Rubiera del Fueyo, MD, PhD; Phone Number: 4997 +34934893000; Email: martaaurora.rubiera@vallhebron.cat

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall Hebron University Hospital
    • Contact: Marian Muchada Lopez, MD, PhD; Phone Number: 4448 +34934893000; Email: mangeles.muchada@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients presenting to the Emergency Department with symptoms of TIA (complete recovery of neurological deficits within <24 hours) or minor stroke (NIHSS ≤ 5)

• Age >18 years.
• Availability of a smartphone for the patient or caregiver.
• Family support and/or formal caregiver.
• Clinical stability during the last 12 hours in the Emergency Department.
• Signed informed consent by the patient and/or family member or legal representative.

Exclusion Criteria:

• Severe stenosis or symptomatic arterial occlusion requiring admission for potential reperfusion and/or arterial revascularization treatments.
• Patients with pre-existing neurological or psychiatric conditions that may interfere with or complicate follow-up and evaluations.
• Clinical (terminal condition) or social (language barrier) impossibility to complete follow-up assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Randomized to be hospitalized at home	Other: Home hospitalization; patients randomized to the treatment group (NORAHOME) to validate that our Home Hospitalization program for patients with TIA or minor stroke; Other Names: Treatment group; Norahome
No Intervention: Control; Randomized to conventional hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy objective	Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.	3months
Primary efficacy objective	Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.	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.	3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Change in direct hospital costs compared to standard clinical practice.	15days
Security	Change in the incidence of complications associated with hospital admission (delirium, nosocomial infections, falls).	15 days
Patient reported outcomes	Change in patient-reported health outcomes (PROMs) and patient experience measures (PREMs) compared to standard clinical practice	3months
Patient information	Change in patient knowledge about stroke and key secondary prevention recommendations after the acute stroke phase.	3months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Hospital Vall d'Hebron; Vall Hebron Insitut Recerca

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): June 29, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Stroke, TIA, Hospitalization at Home, Stroke Care, PROMs, PREMs
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: PR(AG)387/2023; PI22/01928 (Other Identifier: Proyectos de Investigación en Salud- Instituto Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No