Acute StrokeFACTNCT02119598
Feasibility of AmbulanCe-based Telemedicine (FACT) Study
An observational study of Acute Stroke, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments The experience with prehospital telemedicine for assessment of stroke severity is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Sep 2014
- Phase
- Observational
- 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
Study population: Any patient older than 18 years requesting ambulance-based emergency care.
Who may be able to join
- Any patient older than 18 years of age requesting ambulance-based emergency care
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical and Clinical Feasibility of Third Generation In-ambulance Telemedicine: Feasibility of AmbulanCe-based Telemedicine (FACT) Study
Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments
The experience with prehospital telemedicine for assessment of stroke severity is limited. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.
The aim of this prospective study is to investigate the safety, the technical feasibility and the reliability of in-ambulance telemedicine using a prototype third generation telemedicine system (PreSSUB 3.0).
Read the detailed description
Timely treatment can effectively reduce the burden of stroke and should begin with optimal prehospital stroke care. The slogans 'Time is brain' and 'Competence is brain' adequately point out that acute stroke is a time-critical medical emergency requiring specialized treatment.
Pursuant to ongoing technological developments and in line with the American Stroke Association and the European Stroke Organisation guidelines, the implementation of telestroke for optimizing inhospital stroke care is currently applied in several countries. Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments.
The experience with prehospital telemedicine for assessment of stroke severity, however, is limited to the TeleBAT project and two recent pilot studies conducted in healthy volunteers. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.
As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB), we have developed and tested several prototypes for prehospital telemedicine. The current system consists of commercially available hardware and a Web-based telemedicine platform. The data are transmitted to a multimedia server unit over a mobile (ultra)broadband connection (3G or 4G). Data privacy is secured by password-protected logins, role-based access control, and hypertext transfer protocol secure encryption.
The results of a feasibility study using the 4G network in healthy volunteers have recently been reported and feasibility data using the 3G network in healthy volunteers are available.
Building further on the reassuring safety and feasibility data specified above, the next logical step is to evaluate this system for prehospital telemedicine in the real-life situation involving transportation of patients in the Paramedic Ambulance team (PIT)-ambulance to the UZ Brussel.
- Conditions
- Acute Stroke
- Keywords
- Prehospital care, Telemedicine, Ambulance-based telemedicine
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of succesfully executed prehospital teleconsultations
A successful prehospital teleconsultation is defined as a personal interaction between a patient in a moving ambulance and a remote teleconsultant, based on wireless audiovisual communication and optional reporting of vital parameters (e.g. blood pressure, blood oxygen saturation, heart rate, glycemia), neurological deficit, key history taking, medication anamnesis, and/or patient identification.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raf Brouns, MD, PhD, Universitair Ziekenhuis Brussel
- Investigators
- Raf Brouns, M.D., Ph.D., Principal investigator, Department of Neurology, Universitair Ziekenhuis Brussel, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119598
- Sponsor's protocol ID
- B.U.N. 143201317990
- Acronym
- FACT
- Status last verified
- Dec 2014
- First submitted
- 12 Apr 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical and Clinical Feasibility of Third Generation In-ambulance Telemedicine: Feasibility of AmbulanCe-based Telemedicine (FACT) Study
- ClinicalTrials.gov ID
- NCT02119598
- Acronym / sponsor ID
- FACT / B.U.N. 143201317990
- Conditions
- Acute Stroke
- Keywords
- Prehospital care, Telemedicine, Ambulance-based telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments
The experience with prehospital telemedicine for assessment of stroke severity is limited. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.
The aim of this prospective study is to investigate the safety, the technical feasibility and the reliability of in-ambulance telemedicine using a prototype third generation telemedicine system (PreSSUB 3.0).
Detailed description
Timely treatment can effectively reduce the burden of stroke and should begin with optimal prehospital stroke care. The slogans 'Time is brain' and 'Competence is brain' adequately point out that acute stroke is a time-critical medical emergency requiring specialized treatment.
Pursuant to ongoing technological developments and in line with the American Stroke Association and the European Stroke Organisation guidelines, the implementation of telestroke for optimizing inhospital stroke care is currently applied in several countries. Research on prehospital telestroke systems is recommended by the American Stroke Association, as it may facilitate early stroke diagnosis, assessment of stroke severity and selection of patients for specific stroke treatments.
The experience with prehospital telemedicine for assessment of stroke severity, however, is limited to the TeleBAT project and two recent pilot studies conducted in healthy volunteers. Prehospital telestroke is a very promising concept, facilitating specialized stroke care in very early stage based on integration of bidirectional audiovisual communication with point of care laboratory analysis, vitals and decision support software.
As part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB), we have developed and tested several prototypes for prehospital telemedicine. The current system consists of commercially available hardware and a Web-based telemedicine platform. The data are transmitted to a multimedia server unit over a mobile (ultra)broadband connection (3G or 4G). Data privacy is secured by password-protected logins, role-based access control, and hypertext transfer protocol secure encryption.
The results of a feasibility study using the 4G network in healthy volunteers have recently been reported and feasibility data using the 3G network in healthy volunteers are available.
Building further on the reassuring safety and feasibility data specified above, the next logical step is to evaluate this system for prehospital telemedicine in the real-life situation involving transportation of patients in the Paramedic Ambulance team (PIT)-ambulance to the UZ Brussel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient older than 18 years requesting ambulance-based emergency care.
Key inclusion criteria (1 listed)
- Any patient older than 18 years of age requesting ambulance-based emergency care
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of succesfully executed prehospital teleconsultations
Time frame: Up to 26 weeks
A successful prehospital teleconsultation is defined as a personal interaction between a patient in a moving ambulance and a remote teleconsultant, based on wireless audiovisual communication and optional reporting of vital parameters (e.g. blood pressure, blood oxygen saturation, heart rate, glycemia), neurological deficit, key history taking, medication anamnesis, and/or patient identification.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Raf Brouns, M.D., Ph.D. principal investigator
Department of Neurology, Universitair Ziekenhuis Brussel, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of succesfully executed prehospital teleconsultations (time frame: Up to 26 weeks). 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 3 Dec 2014.