StrokeNCT05144932
StrokeAlarm Trial 2
A study testing Stroke Alarm in people with Stroke and Atrial Fibrillation, run by Region Skane at 1 site in Sweden.
Trial summary
This open, multicenter, prospective, singel-arm study will evaluate usability and feasibility of a wearable stroke indication system (Stroke Alarm) in patients with recent TIA, recent minor stroke without persistent arm motor deficit, or atrial fibrillation up to 1 month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation, TIA
- What is being tested?
- Stroke Alarm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patients with 2A. Diagnosed (ICD-10) TIA (G45.9: Transitory ischemic attack or G45.3: Amaurosis fugax, or 2B. ICD-10 ischemic stroke, I63.0-9. 2C. Newly diagnosed atrial fibrillation. 2D. Atrial fibrillation with an increased risk of stroke (contraindication to oral anticoagulants, reduced dose of oral anticoagulants or other risk factors presenting an estimated annual stroke risk of 5% or more despite anticoagulants treatment.
- Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form.
Who cannot join
- Already included in the study in connection with previous TIA/stroke.
- Has an affected arm function due to previous stroke or other illness/trauma.
- Cannot provide informed consent to participation in the study.
- Does not speak Swedish or English in speech and writing.
- Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study.
- Do not want to participate.
- During the study period, do not have access to a compatible smartPhone.
- Not deemed capable of managing the Stroke Alarm smartphone app.
Trial locations and contacts
1 site in 1 country.
Åke Holmberg, MSc contact
Sweden1 site, 1 recruiting
- Recruiting
Hässleholms sjukhus
Hässleholm, 28138
Magnus Esbjörnsson, MD, +46451298753, magnus.esbjornsson@skane.se
About this study
This open, multicenter, prospective, singel-arm study will evaluate usability and feasibility of a wearable stroke indication system (Stroke Alarm) in patients with recent TIA, recent minor stroke without persistent arm motor deficit, or atrial fibrillation up to 1 month.
Read the detailed description
The aim of this study is to test the safety and feasibility of the CE-marked wearable system for early stroke indication to indicate the onset of stroke in real life.
Our hypothesis is that the device is well tolerated with an acceptable number of adverse events such as direct complications of the bracelets or unbearable amounts of false alarms or false alarms during sleep.
The device can be used to monitor arm motor function for long time. The ability to detect arm paresis (indicating the onset of a stroke) will be studied as well, but the trial is single-armed and not designed to assess neither the efficacy of stroke indication nor shortened patient-delay.
Anticipated adverse device effects that are to be assessed.
- Participants being unable to operate the device.
- Frequency of alarms specified for the different alarm escalation steps.
- User compliance.
- User experience.
- Alarm recipient experience
- Barriers for use will be identified (for example advanced age or other patients' characteristics)
This is a prospective trial without a comparator group (single arm). All patients with a diagnosis of stroke (ischemic stroke or intracerebral hemorrhage) or TIA or newly diagnosed atrial fibrillation/flutter at the participating hospitals are screened daily (Monday - Friday) for eligibility by dedicated research nurses, mainly through the electronic patient chart (Melior). Atrial fibrillation patients may also be identtifyed using the Auricula registry for oral anticoagulation. When in doubt about the diagnosis or eligibility for other reasons research nurses consult either the physician responsible for the patient or the PI.
All patients screened are documented, including reasons for non-inclusion and exclusion. The screening log is kept in the Investigators site file (ISF) that are located in locked research offices at the participating hospitals. Source data such as inclusion forms are stored in the same research offices, within locked cabinets.
All included patients are contacted by a research nurse at one month from inclusion (plus maximum 14 days) for a planned follow-up phone call.
The follow-up appointments are scheduled by phone/letter, but prior to the visit, a notice will be sent, and the patient is encouraged to complete the questionnaire before the visit and is also informed that it is possible to complete the questionnaire during the follow-up. Interpreter-assistance or use of questionnaires translated to foreign languages is allowed during the follow-up visit.
The follow-up is estimated to take one hour. Prior to the follow-up the electronic journal is checked for any admissions for stroke or TIA during the follow-up period and in such case any arm motor involvement and the time from onset to arrival to hospital is also registered.
At the follow-up, a structured reporting form is used (StrokeAlarm Pro CRF). Baseline data for all patients are registered in the CRF at inclusion and/or at follow-up.
The research nurse fills in the CRF at inclusion and follow-up and enters the data into SPSS. The PI validates the CRF items in SPSS using cross control and frequencies analysis of number of answers.
Data from the device backend server is extracted by a predefined format (Structured Backend Data Report StrokeAlarm Pro DRF) into the SPSS data file.
Analyses are made on pseudoanonymized data (personal identification number replaced by serial number). A key will be kept in a locked research room at the hospital throughout the course of the study and the analytic phase.
SPSS will be used for all statistical analyses. Data will be summarized and presented with descriptive statistics and graphs, as well as linear models.
The patients are in this clinical trial instructed to use the device continuously for 1 month.
No comparator will be used in this clinical trial. The main reason is that there are no similar systems available. Feasibility is the main research question.
Each patient that are participating in this clinical trial will receive one pair of devices.
The devices are paired and designed for continuous use for up to 6 months. For hygienic reasons the devices will not be re-used for other subjects. The devices will be collected by the manufacturer at the end of the study.
9.2.1 Other medical device or medication to be used during the clinical investigation.
Simultaneous inclusion in other studies that require bracelets are not permitted since this may negatively impact the user experience. Simultaneous inclusion in other ongoing studies on for example drugs, is permitted.
- Conditions
- Stroke, Atrial Fibrillation, TIA
- Being tested
- Stroke Alarm
- Keywords
- wearable device, stroke detection, Stroke Alarm, Accelerometer, Sensor
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke AlarmDevice
The patients are in this clinical trial instructed to use the device continuously for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| StrokeAlarm use | Experimental | This is a single arm study. All participants will be instructed to use the StrokeAlarm medical device for 1 month. Receives: Device: Stroke Alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Usability of the CE marked medical device Stroke Alarm.
Measured: 1 month
Secondary outcomes (1)
Stroke indication
The number of correctly identified stroke events in the study group and the number of stroke events not indicated by the device.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The patients are in this clinical trial instructed to use the device continuously for 1 month. No comparator will be used in this clinical trial. The main reason is that there are no similar systems available. Feasibility is the main research question.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Esbjörnsson, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144932
- Sponsor's protocol ID
- CIV-SE-21-08-037407
- Status last verified
- Mar 2024
- First submitted
- 20 Nov 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be shared upon reasonable request and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrokeAlarm Trial 2
- ClinicalTrials.gov ID
- NCT05144932
- Acronym / sponsor ID
- CIV-SE-21-08-037407
- Conditions
- Stroke, Atrial Fibrillation, TIA
- Keywords
- wearable device, stroke detection, Stroke Alarm, Accelerometer, Sensor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Dec 2021 (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.
This open, multicenter, prospective, singel-arm study will evaluate usability and feasibility of a wearable stroke indication system (Stroke Alarm) in patients with recent TIA, recent minor stroke without persistent arm motor deficit, or atrial fibrillation up to 1 month.
Detailed description
The aim of this study is to test the safety and feasibility of the CE-marked wearable system for early stroke indication to indicate the onset of stroke in real life.
Our hypothesis is that the device is well tolerated with an acceptable number of adverse events such as direct complications of the bracelets or unbearable amounts of false alarms or false alarms during sleep.
The device can be used to monitor arm motor function for long time. The ability to detect arm paresis (indicating the onset of a stroke) will be studied as well, but the trial is single-armed and not designed to assess neither the efficacy of stroke indication nor shortened patient-delay.
Anticipated adverse device effects that are to be assessed.
- Participants being unable to operate the device.
- Frequency of alarms specified for the different alarm escalation steps.
- User compliance.
- User experience.
- Alarm recipient experience
- Barriers for use will be identified (for example advanced age or other patients' characteristics)
This is a prospective trial without a comparator group (single arm). All patients with a diagnosis of stroke (ischemic stroke or intracerebral hemorrhage) or TIA or newly diagnosed atrial fibrillation/flutter at the participating hospitals are screened daily (Monday - Friday) for eligibility by dedicated research nurses, mainly through the electronic patient chart (Melior). Atrial fibrillation patients may also be identtifyed using the Auricula registry for oral anticoagulation. When in doubt about the diagnosis or eligibility for other reasons research nurses consult either the physician responsible for the patient or the PI.
All patients screened are documented, including reasons for non-inclusion and exclusion. The screening log is kept in the Investigators site file (ISF) that are located in locked research offices at the participating hospitals. Source data such as inclusion forms are stored in the same research offices, within locked cabinets.
All included patients are contacted by a research nurse at one month from inclusion (plus maximum 14 days) for a planned follow-up phone call.
The follow-up appointments are scheduled by phone/letter, but prior to the visit, a notice will be sent, and the patient is encouraged to complete the questionnaire before the visit and is also informed that it is possible to complete the questionnaire during the follow-up. Interpreter-assistance or use of questionnaires translated to foreign languages is allowed during the follow-up visit.
The follow-up is estimated to take one hour. Prior to the follow-up the electronic journal is checked for any admissions for stroke or TIA during the follow-up period and in such case any arm motor involvement and the time from onset to arrival to hospital is also registered.
At the follow-up, a structured reporting form is used (StrokeAlarm Pro CRF). Baseline data for all patients are registered in the CRF at inclusion and/or at follow-up.
The research nurse fills in the CRF at inclusion and follow-up and enters the data into SPSS. The PI validates the CRF items in SPSS using cross control and frequencies analysis of number of answers.
Data from the device backend server is extracted by a predefined format (Structured Backend Data Report StrokeAlarm Pro DRF) into the SPSS data file.
Analyses are made on pseudoanonymized data (personal identification number replaced by serial number). A key will be kept in a locked research room at the hospital throughout the course of the study and the analytic phase.
SPSS will be used for all statistical analyses. Data will be summarized and presented with descriptive statistics and graphs, as well as linear models.
The patients are in this clinical trial instructed to use the device continuously for 1 month.
No comparator will be used in this clinical trial. The main reason is that there are no similar systems available. Feasibility is the main research question.
Each patient that are participating in this clinical trial will receive one pair of devices.
The devices are paired and designed for continuous use for up to 6 months. For hygienic reasons the devices will not be re-used for other subjects. The devices will be collected by the manufacturer at the end of the study.
9.2.1 Other medical device or medication to be used during the clinical investigation.
Simultaneous inclusion in other studies that require bracelets are not permitted since this may negatively impact the user experience. Simultaneous inclusion in other ongoing studies on for example drugs, is permitted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients are in this clinical trial instructed to use the device continuously for 1 month. No comparator will be used in this clinical trial. The main reason is that there are no similar systems available. Feasibility is the main research question.
| Arm | Type | Receives |
|---|---|---|
| StrokeAlarm use | Experimental | Device: Stroke AlarmThis is a single arm study. All participants will be instructed to use the StrokeAlarm medical device for 1 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patients with 2A. Diagnosed (ICD-10) TIA (G45.9: Transitory ischemic attack or G45.3: Amaurosis fugax, or 2B. ICD-10 ischemic stroke, I63.0-9. 2C. Newly diagnosed atrial fibrillation. 2D. Atrial fibrillation with an increased risk of stroke (contraindication to oral anticoagulants, reduced dose of oral anticoagulants or other risk factors presenting an estimated annual stroke risk of 5% or more despite anticoagulants treatment.
- Subject has after study specific information consent to participation by signing the Ethics committee-approved inform consent form.
Key exclusion criteria (8 listed)
- Already included in the study in connection with previous TIA/stroke.
- Has an affected arm function due to previous stroke or other illness/trauma.
- Cannot provide informed consent to participation in the study.
- Does not speak Swedish or English in speech and writing.
- Assessed due to other diseases or circumstances in general cannot contribute to planned follow-up within the framework of the study.
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 |
|---|---|---|
| Stroke AlarmThe patients are in this clinical trial instructed to use the device continuously for 1 month. | Device | StrokeAlarm use |
Primary outcome
Usability
Time frame: 1 month
Usability of the CE marked medical device Stroke Alarm.
1 secondary outcome
Stroke indication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Anonymized data may be shared upon reasonable request and ethical approval.
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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. This study is not recruiting at the moment.
Åke Holmberg, MSc contact
Magnus Esbjörnsson, MD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Alarm in people with Stroke and Atrial Fibrillation, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Wasselius, MD, PhD (+4646173082, johan.wasselius@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 1 month). 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 12 Mar 2024.