AzTrials
AzTrials

Stroke (CVA) or TIANORAHOMENCT07500116

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

A study testing Home hospitalization in people with Stroke (CVA) or TIA and Stroke Recurrence, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke (CVA) or TIA, Stroke Recurrence
What is being tested?
Home hospitalization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteSpain
Study dates
29 Jan 2025to 29 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marian Muchada Lopez, MD, PHD contact

+34 934893000 ext. 4448

mangeles.muchada@vallhebron.cat

Marta Rubiera del Fueyo, MD, PhD contact

+34934893000 ext. 4997

martaaurora.rubiera@vallhebron.cat

Spain1 site, 1 recruiting
  • Vall Hebron University Hospital

    Barcelona, 08035

    Marian Muchada Lopez, MD, PhD, +34934893000 ext. 4448, mangeles.muchada@vallhebron.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Home hospitalization
Keywords
Stroke, TIA, Hospitalization at Home, Stroke Care, PROMs, PREMs
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home hospitalizationOther

    Also called Norahome, Treatment group

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

Study groups in NCT07500116
Study groupRoleWhat they receive
TreatmentExperimentalRandomized to be hospitalized at home
Receives: Other: Home hospitalization
ControlNo interventionRandomized to conventional hospitalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy objective

    Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.

    Measured: 3months

  2. Primary efficacy objective

    Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.

    Measured: 3 months

  3. Primary safety objective

    Change in the number of complications (falls, recurrences, infections) in patients with TIA/minor stroke compared to standard clinical practice.

    Measured: 3months

Secondary outcomes (4)
  1. Effectiveness

    Change in direct hospital costs compared to standard clinical practice.

    Measured: 15days

  2. Security

    Change in the incidence of complications associated with hospital admission (delirium, nosocomial infections, falls).

    Measured: 15 days

  3. Patient reported outcomes

    Change in patient-reported health outcomes (PROMs) and patient experience measures (PREMs) compared to standard clinical practice

    Measured: 3months

  4. Patient information

    Change in patient knowledge about stroke and key secondary prevention recommendations after the acute stroke phase.

    Measured: 3months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start29 Jan 2025
  3. Primary completion29 Jun 2027 (estimated)
  4. Study completion29 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07500116
Sponsor's protocol ID
PR(AG)387/2023
Other IDs
PI22/01928
Acronym
NORAHOME
Status last verified
Mar 2026
First submitted
11 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in