NORA-HOME: An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient … (NCT07500116) | Clinical Trial Compass
RecruitingNot Applicable
NORA-HOME: An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks
Spain250 participantsStarted 2025-01-29
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is monitoring people at home after a minor stroke or TIA — can you explain what 'multimodal monitoring' means in practice, and what devices or check-ins I would actually need to do day-to-day if I were to participate?
2Since this study is listed as 'Phase NA,' it sounds like it may be more of an observational or monitoring study rather than a treatment trial — does that mean I wouldn't be changing any of my current medications or therapies, and how does that affect what I might gain or risk by joining?
3The trial is measuring both efficacy and safety as primary objectives — what specific risks or burdens is the safety objective watching out for, and are there any concerns particular to people in my situation with a recent minor stroke or TIA?
4Given that this trial is focused on ambulatory, or at-home, monitoring for stroke recurrence, how would the study team respond if the monitoring picked up a warning sign — would I get faster access to care, or is that data mainly used for research purposes?
5Would taking part in this home-monitoring study interfere with or delay any standard treatments or follow-up care you'd normally recommend after a minor stroke or TIA, and is there a reason you might suggest I pursue standard care alone instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary efficacy objective
Timeframe: 3months
2
Primary efficacy objective
Timeframe: 3 months
3
Primary safety objective
Timeframe: 3months
Trial details
NCT IDNCT07500116
SponsorHospital Universitari Vall d'Hebron Research Institute