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.
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
- Are there results?
- Not yet: the study is under way
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.
Spain1 site, 1 recruiting
- Recruiting
Vall Hebron University Hospital
Barcelona, 08035
Marian Muchada Lopez, MD, PhD, +34934893000 ext. 4448, mangeles.muchada@vallhebron.cat
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.
- Conditions
- Stroke (CVA) or TIA, Stroke Recurrence
- 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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Randomized to be hospitalized at home Receives: Other: Home hospitalization |
| Control | No intervention | Randomized to conventional hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy objective
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Measured: 3months
Primary efficacy objective
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Measured: 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.
Measured: 3months
Secondary outcomes (4)
Effectiveness
Change in direct hospital costs compared to standard clinical practice.
Measured: 15days
Security
Change in the incidence of complications associated with hospital admission (delirium, nosocomial infections, falls).
Measured: 15 days
Patient reported outcomes
Change in patient-reported health outcomes (PROMs) and patient experience measures (PREMs) compared to standard clinical practice
Measured: 3months
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.
- First posted30 Mar 2026
- Study start29 Jan 2025
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (CVA) or TIAStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vall Hebron Insitut Recerca, Hospital Vall d'Hebron
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NORA-HOME. Efficiency And Safety An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks
- ClinicalTrials.gov ID
- NCT07500116
- Acronym / sponsor ID
- NORAHOME / PR(AG)387/2023
- Conditions
- Stroke (CVA) or TIA, Stroke Recurrence
- Keywords
- Stroke, TIA, Hospitalization at Home, Stroke Care, PROMs, PREMs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Vall Hebron Insitut Recerca, Hospital Vall d'Hebron
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Home hospitalizationRandomized to be hospitalized at home |
| Control | No intervention | –Randomized to conventional hospitalization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home hospitalizationAlso: Norahome, Treatment grouppatients randomized to the treatment group (NORAHOME) to validate that our Home Hospitalization program for patients with TIA or minor stroke | Other | Treatment |
Primary outcome
Primary efficacy objective
Time frame: 3months
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Primary efficacy objective
Time frame: 3 months
Change in the rate of early recurrence and hospital readmission compared to standard clinical practice.
Primary safety objective
Time frame: 3months
Change in the number of complications (falls, recurrences, infections) in patients with TIA/minor stroke compared to standard clinical practice.
4 secondary outcomes
Effectiveness
Time frame: 15days
Security
Time frame: 15 days
Patient reported outcomes
Time frame: 3months
Patient information
Time frame: 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian Muchada Lopez, MD, PHD (+34 934893000 ext. 4448, mangeles.muchada@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy objective (time frame: 3months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.