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Recruiting NCT07500116

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

No phase Interventional Stroke (CVA) or TIA Stroke Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home hospitalization.
Who it may be relevant to
Registry conditions: Stroke (CVA) or TIA, Stroke Recurrence. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Home hospitalization
    patients randomized to the treatment group (NORAHOME) to validate that our Home Hospitalization program for patients with TIA or minor stroke

Primary outcome measures

  • Primary efficacy objective [Time frame: 3months]
  • Primary efficacy objective [Time frame: 3 months]
  • Primary safety objective [Time frame: 3months]
Secondary outcome measures (4)
  • Effectiveness [Time frame: 15days]
  • Security [Time frame: 15 days]
  • Patient reported outcomes [Time frame: 3months]
  • Patient information [Time frame: 3months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Vall Hebron University Hospital — Barcelona

Identifiers

NCT: NCT07500116 · PR(AG)387/2023 · PI22/01928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗