NCT06613828

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
435

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

September 23, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

Stroke Symptom RecognitionMnemonic-based educationstroke awarenessSpanish-speaking populationPublic health intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-intervention and 7 days post-intervention.

Secondary Outcomes (1)

  • Proportion of Participants with Adequate Knowledge of Stroke Symptoms

    7 days post-intervention.

Study Arms (5)

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.

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.

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.

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.

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.

Behavioral: Mnemonic-Based Educational Training for Stroke Symptom Recognition

Interventions

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).

CAMALEON Strategy ArmCORRE Strategy ArmDALE Strategy ArmICTUS 911 Strategy ArmRAPIDO Strategy Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Participants must be 18 years or older.
  • Consent: Participants must provide informed consent to participate in the study.

You may not qualify if:

  • Language: Participants must be fluent in Spanish, as the educational interventions are based on Spanish-language mnemonic strategies.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Zona #2

Aguascalientes, Aguascalientes, 20190, Mexico

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

April 1, 2024

Primary Completion

October 20, 2024

Study Completion

November 7, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations