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

NCT07500116 | Recruiting

• 2 other identifiers: PR(AG)387/2023PI22/01928
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke (CVA) or TIA; Stroke Recurrence

Keywords

Stroke, TIA, Hospitalization at Home, Stroke Care, PROMs, PREMs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Effectiveness

  15days

• Security

  15 days

• Patient reported outcomes

  3months

• Patient information

  3months

Study Arms (2)

Treatment

EXPERIMENTAL

Randomized to be hospitalized at home

Other: Home hospitalization

Control

NO INTERVENTION

Randomized to conventional hospitalization

Interventions

Home hospitalization OTHER

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

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Vall Hebron Insitut Recerca: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Vall Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Central Study Contacts

Marian Muchada Lopez, MD, PHD

CONTACT

+34 934893000; mangeles.muchada@vallhebron.cat

Marta Rubiera del Fueyo, MD, PhD

CONTACT

+34934893000; martaaurora.rubiera@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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, SCP). Candidates will be recruited over a 24-month period. After completing a 3-month follow-up period, a comparative statistical analysis between the treatment and control groups will be conducted.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 30, 2026
• Study Start: January 29, 2025
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): June 29, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)