Stroke, CardiovascularNCT04699409
The Comparison of Educational Effectiveness Between FAST and STROKE 112 in Yunlin Community
A study testing stroke educational campaign: FAST and stroke educational campaign: STROKE 112 in people with Stroke, Cardiovascular, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
FAST and Stroke-112 are two campaigns to reduce the emergency room arrival time of stroke patients. No study has evaluated the effectiveness of these campaigns. This study aimed to compare recalling capacity of people in these two campaigns. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- stroke educational campaign: FAST and stroke educational campaign: STROKE 112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 20
- individuals who could speak either Mandarin or Taiwanese as their mother tongue
Who cannot join
- individuals who could not understanding the education campaign(ex. dementia, aphasia)
- individuals who were previously aware about either campaign
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu
Dr. Tsai, +886055323911 ext. 55687
About this study
FAST and Stroke-112 are two campaigns to reduce the emergency room arrival time of stroke patients. No study has evaluated the effectiveness of these campaigns. This study aimed to compare recalling capacity of people in these two campaigns.
Read the detailed description
Cerebral vascular accidents have been one of the leading causes of death in Taiwan in recent years. In the modern medical system, treatment for hyperacute stroke including intravenous thrombolysis and intra-arterial thrombectomy. The faster patient received treatment, the better outcome he has.
Prehospital delay of acute stroke treatment has been an important issue in modern medical system. Awareness of stroke symptoms and calling for medical help immediately is the most important part of stroke health education. The most used educational campaign is FAST.
In recent years, there is another stroke educational campaign called STROKE 112. Previous study had showed it has greater acceptance, since the number is easier to remember then letter, especially in non-English speaking countries.
The investigators had conducted a hospital-based randomized study in 2019, which revealed that STROKE 112 had similar, but not superior effectiveness with FAST. However, more study is needed for community-based population.
This study will compare and explore the effectiveness of two stroke educational campaigns, FAST and STROKE 112, on community-based population by using the questionnaire, in Yunlin, Taiwan. The result will been compared and analyzed with previous study, help us modify and enhance our current stroke educational program, shorten the prehospital delay, and improve outcomes of patients with acute stroke.
The subjects will be randomized into either group: FAST or STROKE 112. Then the investigator will give a 15min eduacation. The evaluation will be arranged 5 days and 30 days after the first education, and the outcome is the recalling capacity of the stroke symptoms in the educational campaign.
- Conditions
- Stroke, Cardiovascular
- Being tested
- stroke educational campaign: FAST, stroke educational campaign: STROKE 112
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke educational campaign: FASTOther
After randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures.
stroke educational campaign: STROKE 112Other
After randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures.
| Study group | Role | What they receive |
|---|---|---|
| FAST | Experimental | stroke education: FAST Receives: Other: stroke educational campaign: FAST |
| STROKE 112 | Experimental | stroke education: STROKE 112 Receives: Other: stroke educational campaign: STROKE 112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recalling capacity of the stroke symptoms mentioned in each campaign
Compare recalling capacity of people in these two campaigns: uneven face, weak arm, slurred speech. If the patient could recall one symptom, then he get 1 score. Total score is 3(which means the subject can recall all three symptoms)
Measured: 5 days
The recalling capacity of the stroke symptoms mentioned in each campaign
Compare recalling capacity of people in these two campaigns: uneven face, weak arm, slurred speech. If the patient could recall one symptom, then he get 1 score. Total score is 3(which means the subject can recall all three symptoms)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jan 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YiTe Tsai, Bachelor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699409
- Sponsor's protocol ID
- 202009041RIND
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Educational Effectiveness Between FAST and STROKE 112 in Yunlin Community
- ClinicalTrials.gov ID
- NCT04699409
- Acronym / sponsor ID
- 202009041RIND
- Conditions
- Stroke, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Jan 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.
FAST and Stroke-112 are two campaigns to reduce the emergency room arrival time of stroke patients. No study has evaluated the effectiveness of these campaigns. This study aimed to compare recalling capacity of people in these two campaigns.
Detailed description
Cerebral vascular accidents have been one of the leading causes of death in Taiwan in recent years. In the modern medical system, treatment for hyperacute stroke including intravenous thrombolysis and intra-arterial thrombectomy. The faster patient received treatment, the better outcome he has.
Prehospital delay of acute stroke treatment has been an important issue in modern medical system. Awareness of stroke symptoms and calling for medical help immediately is the most important part of stroke health education. The most used educational campaign is FAST.
In recent years, there is another stroke educational campaign called STROKE 112. Previous study had showed it has greater acceptance, since the number is easier to remember then letter, especially in non-English speaking countries.
The investigators had conducted a hospital-based randomized study in 2019, which revealed that STROKE 112 had similar, but not superior effectiveness with FAST. However, more study is needed for community-based population.
This study will compare and explore the effectiveness of two stroke educational campaigns, FAST and STROKE 112, on community-based population by using the questionnaire, in Yunlin, Taiwan. The result will been compared and analyzed with previous study, help us modify and enhance our current stroke educational program, shorten the prehospital delay, and improve outcomes of patients with acute stroke.
The subjects will be randomized into either group: FAST or STROKE 112. Then the investigator will give a 15min eduacation. The evaluation will be arranged 5 days and 30 days after the first education, and the outcome is the recalling capacity of the stroke symptoms in the educational campaign.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST | Experimental | Other: stroke educational campaign: FASTstroke education: FAST |
| STROKE 112 | Experimental | Other: stroke educational campaign: STROKE 112stroke education: STROKE 112 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 20
- individuals who could speak either Mandarin or Taiwanese as their mother tongue
Key exclusion criteria (2 listed)
- individuals who could not understanding the education campaign(ex. dementia, aphasia)
- individuals who were previously aware about either campaign
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 educational campaign: FASTAfter randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures. | Other | FAST |
| stroke educational campaign: STROKE 112After randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures. | Other | STROKE 112 |
Primary outcome
The recalling capacity of the stroke symptoms mentioned in each campaign
Time frame: 5 days
Compare recalling capacity of people in these two campaigns: uneven face, weak arm, slurred speech. If the patient could recall one symptom, then he get 1 score. Total score is 3(which means the subject can recall all three symptoms)
The recalling capacity of the stroke symptoms mentioned in each campaign
Time frame: 30 days
Compare recalling capacity of people in these two campaigns: uneven face, weak arm, slurred speech. If the patient could recall one symptom, then he get 1 score. Total score is 3(which means the subject can recall all three symptoms)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
YiTe Tsai, Bachelor principal investigator
National Taiwan University Hospital
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 educational campaign: FAST and stroke educational campaign: STROKE 112 in people with Stroke, Cardiovascular, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 7 Jan 2021. 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 Taiwan. 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 YiTe Tsai, Bachelor (+886972655687, duckeryite@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recalling capacity of the stroke symptoms mentioned in each campaign (time frame: 5 days). The study lists 2 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 7 Jan 2021.