Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome

Sponsor
Sergio Mies Padilla
Study ID
NCT07402642
Status
Recruiting
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Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Motivational and Individualized Interviewing — BEHAVIORAL
    Used to verify the patient's understanding of their condition and to motivate behavioral changes.
  • Heart-Healthy Dietary Education — BEHAVIORAL
    Specific counseling to improve adherence to the Mediterranean diet and address overweight or obesity
  • Tobacco Cessation Approach — BEHAVIORAL
    Interventions aimed at increasing motivation to quit smoking and reducing nicotine dependence
  • Physical Activity Promotion — BEHAVIORAL
    Personalized exercise recommendations tailored to the patient's clinical status
  • Emotional Health Management — BEHAVIORAL
    Professional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event.
  • Therapeutic Adherence Reinforcement — BEHAVIORAL
    Continuous education and monitoring to ensure compliance with the prescribed pharmacological plan
  • Self-Control Training — BEHAVIORAL
    Training the patient for autonomous monitoring of risk factors, such as blood pressure
  • Use of Educational Resources — BEHAVIORAL
    Provision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors
  • Cardiac Rehabilitation Program — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
Jan 12, 2026
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
256 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Experimental Group
    The 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.
  • Active Comparator: Control Group
    The 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.

Primary Outcome Measure

Cardiac Self-Efficacy [ Time Frame: 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 ]

Central Contacts

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