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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Home hospitalization

    Other intervention

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary efficacy objective

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

Time frame
3months
2

Primary efficacy objective

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

Time frame
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.

Time frame
3months

Secondary outcomes

1

Effectiveness

Change in direct hospital costs compared to standard clinical practice.

Time frame
15days
2

Security

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

Time frame
15 days
3

Patient reported outcomes

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

Time frame
3months
4

Patient information

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

Time frame
3months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari Vall d'Hebron Research Institute

Lead sponsor

Vall Hebron Insitut Recerca

Collaborator

Hospital Vall d'Hebron

Collaborator