Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome
1 other identifier
interventional
256
1 country
1
Brief Summary
Early Education After a Heart Attack What is the purpose of this study? The main goal is to evaluate if a special nursing education and support program helps patients who have suffered a heart attack feel more confident in managing their own health. Researchers want to see if this extra support improves how patients care for their hearts through diet, physical activity, and quitting smoking. The study compares this new nursing strategy against the standard care patients usually receive. Who can participate? Participants must be 18 years of age or older. People who have recently had a heart attack requiring an urgent heart catheterization at the Complejo Hospitalario Universitario Insular Materno Infantil. Exclusions: People with significant language barriers (Spanish), mental incapacity to follow recommendations, or those unable to attend in-person consultations cannot participate. What will happen during the study? Participants will be divided into two groups: Standard Care Group (Control): These participants will receive the usual medical follow-up and standard cardiac rehabilitation sessions (an average of 17 sessions focused on exercise and group education). Special Support Group (Experimental): In addition to standard care, these participants will have a specific nursing consultation consisting of 4 scheduled visits. These visits are a mix of in-person and telephone appointments.Nurses will provide personalized educational materials, such as infographics, and teach techniques to control blood pressure, improve diet, exercise safely, and manage emotions after a heart attack. Duration and Follow-up Each participant will be followed for approximately 8 months. During this time, they will be asked to complete several surveys about their lifestyle. Researchers will also review blood test results (cholesterol levels) from their medical records to track progress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2026
CompletedFirst Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 11, 2026
January 1, 2026
12 months
January 28, 2026
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac Self-Efficacy
His measure evaluates specific behaviors related to cardiovascular health using the Spanish-validated version of the Cardiac Self-Efficacy Scale (S-CSE). This tool consists of 12 items across three dimensions: symptom control, disease control, and activity maintenance. Each item is rated on a 7-point Likert scale (1 = not at all confident, 7 = completely confident). Total scores range from 12 to 84, where higher scores indicate better self-efficacy
Experimental Group: measured at two time points: baseline (during hospitalization) and 8 months (post-coronary event). Control Group: measured only at the 8-month mark post-coronary event to evaluate the level of self-efficacy after receiving standard
Secondary Outcomes (7)
Adherence to the Mediterranean Diet
Experimental Group: baseline and 8 months Control Group: 8 months only
Nicotine Dependence
Experimental Group: baseline and 8 months Control Group: 8 months only
Motivation to Quit Smoking
Experimental Group: Baseline and 8 months . Control Group: 8 months only.
Physical Activity Level
Experimental Group: Baseline and 8 months Control Group: 8 months only.
Affective State (Anxiety and Depression)
Experimental Group: Baseline and 8 months Control Group: 8 months only
- +2 more secondary outcomes
Study Arms (2)
Experimental Group
EXPERIMENTALThe intervention for the experimental group consists of specialized and structured nursing care provided in addition to standard medical treatment. This program is organized into four key stages: it begins with an initial contact during hospital admission to explain the objectives and assess baseline risks. Subsequently, between 7 and 10 days after discharge, a 60-minute in-person visit is conducted to perform a complete medical history and deliver adapted educational materials on heart-healthy habits. Four months after the event, a telephone reinforcement session is held to monitor treatment adherence and lifestyle changes. Finally, eight months after discharge, an in-person evaluation is carried out to measure the achievement of goals and, if necessary, refer the patient to other specialists. The entire process is supported by the use of infographics and evidence-based educational materials focused on blood pressure control, diet, exercise, and emotional health.
Control Group
ACTIVE COMPARATORThe Control Group consists of patients who receive the standard healthcare provided by the hospital after a heart attack. These participants are recruited retrospectively using the hospital's hemodynamic service records. After discharge, they participate in the standard cardiac rehabilitation program, which typically includes 17 sessions of physical exercise and group health education. Their data is collected through a single telephone interview approximately 8 months after their heart attack to evaluate their lifestyle habits, emotional state, and clinical progress.
Interventions
Specific counseling to improve adherence to the Mediterranean diet and address overweight or obesity
Interventions aimed at increasing motivation to quit smoking and reducing nicotine dependence
Personalized exercise recommendations tailored to the patient's clinical status
Professional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event.
Continuous education and monitoring to ensure compliance with the prescribed pharmacological plan
Training the patient for autonomous monitoring of risk factors, such as blood pressure
Provision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors
Upon hospital discharge, all patients are referred to a cardiac rehabilitation unit. The program consists of an average of 17 sessions focused primarily on the physical rehabilitation of the patient. Patients receive group-based health education provided by nursing professionals during these sessions.These rehabilitation sessions are typically completed within three months following the coronary event. Patients continue to receive medical and nursing attention through specialized care centers or primary care. Both groups receive optimal pharmacological treatment and general advice on cardiovascular health, including physical activity and diet.
Used to verify the patient's understanding of their condition and to motivate behavioral changes.
Eligibility Criteria
You may qualify if:
- Patients must have suffered an Acute Myocardial Infarction.
- Participants must have undergone an urgent cardiac catheterization.
- Specifically, this includes patients who received coronary reperfusion strategies following the activation of the CODICAN protocol (assistance for ST-segment elevation myocardial infarction) within the study environment.
You may not qualify if:
- Patients with little or no knowledge of the Spanish language that prevents effective communication or reading of educational resources.
- Patients unable to understand their participation or follow health recommendations independently.
- Patients with an unfavorable clinical prognosis or those requiring hospitalization for a period exceeding established limits.
- Patients unable to attend in-person nursing consultations due to personal reasons or place of residence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35001, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nurse doctor in the research support unit
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 11, 2026
Study Start
January 12, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
February 11, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Currently, there is no plan to share individual participant data (IPD) with external researchers or public platforms. According to the protocol, the collected data will be used exclusively for the research purposes of this specific study, and only the research team will have access to the anonymized database. Patient privacy is protected by current regulations (Spanish Organic Law 3/2018), ensuring that information is treated confidentially and securely within the hospital environment.