Stroke AcuteNCT06613828
Efficacy of Five Strategies To Improve Stroke Awareness in the Spanish-Speaking Population
A study testing Mnemonic-Based Educational Training for Stroke Symptom Recognition in people with Stroke Acute, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The goal of this experimental study is to evaluate the efficacy of five educational strategies for recognizing early symptoms of cerebrovascular disease (CVD) in the general adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Mnemonic-Based Educational Training for Stroke Symptom Recognition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2024to 7 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Participants must be 18 years or older.
- Consent: Participants must provide informed consent to participate in the study.
- General Population: Participants from the general public, regardless of their health insurance status or previous medical history (except as specified in exclusion criteria).
- Language: Participants must be fluent in Spanish, as the educational interventions are based on Spanish-language mnemonic strategies.
Who cannot join
- History of Stroke: Participants with a previous diagnosis of cerebrovascular disease (stroke) will be excluded.
- Cognitive Impairment: Participants who are unable to understand or complete the Stroke Awareness Questionnaire (SAQ) due to cognitive or communication impairments will not be eligible.
- Incomplete Evaluation: Participants who are unable to complete both the pre- and post-intervention assessments will be excluded from the study.
- Elimination Criteria:
- Lack of Follow-Up: Participants who fail to attend the second evaluation (7 days post-intervention) will be excluded from the final analysis.
- Withdrawal of Consent: Participants who choose to withdraw from the study at any time will be eliminated from further participation.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this experimental study is to evaluate the efficacy of five educational strategies for recognizing early symptoms of cerebrovascular disease (CVD) in the general adult population. The main questions it aims to answer are:
- How effective are the strategies RAPIDO, CORRE, DALE, CAMALEON, and ICTUS 911 in improving the recognition of early CVD symptoms?
Read more
Researchers will compare these strategies to determine which one leads to the highest increase in symptom recognition. Participants will receive a brief educational session on one of the five strategies and will:
- Complete a pre- and post-intervention survey (Stroke Awareness Questionnaire, SAQ).
- Receive short training on CVD symptoms and the urgency of contacting emergency services.
The primary outcome is the improvement in SAQ scores, and the secondary outcome is the proportion of participants achieving adequate knowledge of CVD symptoms.
- Conditions
- Stroke Acute
- Being tested
- Mnemonic-Based Educational Training for Stroke Symptom Recognition
- Keywords
- Stroke Symptom Recognition, Mnemonic-based education, stroke awareness, Spanish-speaking population, Public health intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mnemonic-Based Educational Training for Stroke Symptom RecognitionBehavioural
This is a Culturally Adapted Mnemonic-Based Educational Strategies for Rapid Stroke Symptom Recognition in the Spanish-Speaking Population.
It uses five distinct mnemonic strategies (RAPIDO, CORRE, DALE, CAMALEON, ICTUS 911), each specifically tailored for a Spanish-speaking audience.
Aims to improve the recognition of early cerebrovascular disease symptoms, differentiating it from other clinical studies that might focus on different health conditions or target populations.
Emphasizes its focus on rapid action by educating participants about stroke symptoms and the importance of contacting emergency services (911).
| Study group | Role | What they receive |
|---|---|---|
| RAPIDO Strategy Arm | Experimental | Participants in this arm receive educational training based on the RAPIDO strategy, an acronym developed to raise awareness of stroke symptoms among the Spanish-speaking community. This strategy is modeled after the English FAST mnemonic and focuses on the rapid identification of stroke symptoms. Receives: Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition |
| CORRE Strategy Arm | Experimental | Participants in this arm are trained using the CORRE strategy, created by a Colombian neurologist. It mirrors the structure of other mnemonic-based interventions and emphasizes the importance of quickly recognizing and acting upon early stroke symptoms. Receives: Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition |
| DALE Strategy Arm | Experimental | Participants in this arm are educated using the DALE strategy, developed in 2012 by researchers at the University of Guadalajara. Similar to the RAPIDO strategy, DALE adapts the FAST mnemonic for the Spanish-speaking population, promoting quick recognition and response to cerebrovascular symptoms. Receives: Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition |
| CAMALEON Strategy Arm | Experimental | In this arm, participants receive training based on the CAMALEON strategy, a mnemonic created in Costa Rica with the support of the pharmaceutical industry. The approach is designed to facilitate the recognition of early stroke symptoms by adapting the FAST mnemonic to Spanish. Receives: Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition |
| ICTUS 911 Strategy Arm | Experimental | Participants in this arm are educated using the ICTUS 911 strategy, which differs from the other four in that it is not directly based on a literal translation of FAST. Instead, it focuses on recognizing stroke symptoms and immediately calling emergency services (911) upon suspicion of a stroke. Receives: Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stroke Awareness Questionnaire (SAQ) Score
This measure will assess the change in participants\' knowledge of stroke symptoms before and after receiving the educational intervention. The SAQ evaluates awareness of stroke symptoms, risk factors, and appropriate responses to suspected stroke events.
Measured: Pre-intervention and 7 days post-intervention.
Secondary outcomes (1)
Proportion of Participants with Adequate Knowledge of Stroke Symptoms
This outcome measures the proportion of participants who achieve a predetermined \"adequate knowledge\" score on the SAQ, defined as correctly identifying at least 3 stroke symptoms and understanding the need to contact emergency services (911) within 3 hours of symptom onset.
Measured: 7 days post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Apr 2024
- Primary completion20 Oct 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke AcuteStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613828
- Sponsor's protocol ID
- F-2024-101-181
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marquez-Romero JM, Sanchez-Ramirez KI, Perez-Malagon CD, Padilla-Lopez J, Ford GA, Zhao J, Liu R. Efficacy of five strategies to improve stroke action awareness in Spanish-speaking adults: A randomized comparison. Int J Stroke. 2026 Mar;21(3):419-429. doi: 10.1177/17474930251378229. Epub 2025 Aug 30.
PubMed 40884082
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Five Strategies To Improve Stroke Awareness in the Spanish-Speaking Population
- ClinicalTrials.gov ID
- NCT06613828
- Acronym / sponsor ID
- F-2024-101-181
- Conditions
- Stroke Acute
- Keywords
- Stroke Symptom Recognition, Mnemonic-based education, stroke awareness, Spanish-speaking population, Public health intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 26 Sep 2024 (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.
The goal of this experimental study is to evaluate the efficacy of five educational strategies for recognizing early symptoms of cerebrovascular disease (CVD) in the general adult population. The main questions it aims to answer are:
- How effective are the strategies RAPIDO, CORRE, DALE, CAMALEON, and ICTUS 911 in improving the recognition of early CVD symptoms?
Researchers will compare these strategies to determine which one leads to the highest increase in symptom recognition. Participants will receive a brief educational session on one of the five strategies and will:
- Complete a pre- and post-intervention survey (Stroke Awareness Questionnaire, SAQ).
- Receive short training on CVD symptoms and the urgency of contacting emergency services.
The primary outcome is the improvement in SAQ scores, and the secondary outcome is the proportion of participants achieving adequate knowledge of CVD symptoms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RAPIDO Strategy Arm | Experimental | Behavioral: Mnemonic-Based Educational Training for Stroke Symptom RecognitionParticipants in this arm receive educational training based on the RAPIDO strategy, an acronym developed to raise awareness of stroke symptoms among the Spanish-speaking community. This strategy is modeled after the English FAST mnemonic and focuses on the rapid identification of stroke symptoms. |
| CORRE Strategy Arm | Experimental | Behavioral: Mnemonic-Based Educational Training for Stroke Symptom RecognitionParticipants in this arm are trained using the CORRE strategy, created by a Colombian neurologist. It mirrors the structure of other mnemonic-based interventions and emphasizes the importance of quickly recognizing and acting upon early stroke symptoms. |
| DALE Strategy Arm | Experimental | Behavioral: Mnemonic-Based Educational Training for Stroke Symptom RecognitionParticipants in this arm are educated using the DALE strategy, developed in 2012 by researchers at the University of Guadalajara. Similar to the RAPIDO strategy, DALE adapts the FAST mnemonic for the Spanish-speaking population, promoting quick recognition and response to cerebrovascular symptoms. |
| CAMALEON Strategy Arm | Experimental | Behavioral: Mnemonic-Based Educational Training for Stroke Symptom RecognitionIn this arm, participants receive training based on the CAMALEON strategy, a mnemonic created in Costa Rica with the support of the pharmaceutical industry. The approach is designed to facilitate the recognition of early stroke symptoms by adapting the FAST mnemonic to Spanish. |
| ICTUS 911 Strategy Arm | Experimental | Behavioral: Mnemonic-Based Educational Training for Stroke Symptom RecognitionParticipants in this arm are educated using the ICTUS 911 strategy, which differs from the other four in that it is not directly based on a literal translation of FAST. Instead, it focuses on recognizing stroke symptoms and immediately calling emergency services (911) upon suspicion of a stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Participants must be 18 years or older.
- Consent: Participants must provide informed consent to participate in the study.
- General Population: Participants from the general public, regardless of their health insurance status or previous medical history (except as specified in exclusion criteria).
- Language: Participants must be fluent in Spanish, as the educational interventions are based on Spanish-language mnemonic strategies.
Key exclusion criteria (6 listed)
- History of Stroke: Participants with a previous diagnosis of cerebrovascular disease (stroke) will be excluded.
- Cognitive Impairment: Participants who are unable to understand or complete the Stroke Awareness Questionnaire (SAQ) due to cognitive or communication impairments will not be eligible.
- Incomplete Evaluation: Participants who are unable to complete both the pre- and post-intervention assessments will be excluded from the study.
- Lack of Follow-Up: Participants who fail to attend the second evaluation (7 days post-intervention) will be excluded from the final analysis.
- Withdrawal of Consent: Participants who choose to withdraw from the study at any time will be eliminated from further participation.
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 |
|---|---|---|
| Mnemonic-Based Educational Training for Stroke Symptom RecognitionThis is a Culturally Adapted Mnemonic-Based Educational Strategies for Rapid Stroke Symptom Recognition in the Spanish-Speaking Population. It uses five distinct mnemonic strategies (RAPIDO, CORRE, DALE, CAMALEON, ICTUS 911), each specifically tailored for a Spanish-speaking audience. Aims to improve the recognition of early cerebrovascular disease symptoms, differentiating it from other clinical studies that might focus on different health conditions or target populations. Emphasizes its focus on rapid action by educating participants about stroke symptoms and the importance of contacting emergency services (911). | Behavioural | CAMALEON Strategy Arm, CORRE Strategy Arm, DALE Strategy Arm, ICTUS 911 Strategy Arm, RAPIDO Strategy Arm |
Primary outcome
Change in Stroke Awareness Questionnaire (SAQ) Score
Time frame: Pre-intervention and 7 days post-intervention.
This measure will assess the change in participants\' knowledge of stroke symptoms before and after receiving the educational intervention. The SAQ evaluates awareness of stroke symptoms, risk factors, and appropriate responses to suspected stroke events.
1 secondary outcome
Proportion of Participants with Adequate Knowledge of Stroke Symptoms
Time frame: 7 days post-intervention.
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 1 May 2025.
- Derived from this study: PubMed 40884082Marquez-Romero JM, Sanchez-Ramirez KI, Perez-Malagon CD, Padilla-Lopez J, Ford GA, Zhao J, Liu R. Efficacy of five strategies to improve stroke action awareness in Spanish-speaking adults: A randomized comparison. Int J Stroke. 2026 Mar;21(3):419-429. doi: 10.1177/17474930251378229. Epub 2025 Aug 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mnemonic-Based Educational Training for Stroke Symptom Recognition in people with Stroke Acute, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 4 inclusion and 6 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 1 May 2025. 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 Mexico. 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?
Change in Stroke Awareness Questionnaire (SAQ) Score (time frame: Pre-intervention and 7 days post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613828, which also lists 1 linked publication.
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 1 May 2025.