Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Cardiac Self-Efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Motivational and Individualized Interviewing (Behavioral)
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.
干预措施: Heart-Healthy Dietary Education (Behavioral)
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.
干预措施: Tobacco Cessation Approach (Behavioral)
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.
干预措施: Physical Activity Promotion (Behavioral)
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.
干预措施: Emotional Health Management (Behavioral)
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.
干预措施: Therapeutic Adherence Reinforcement (Behavioral)
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.
干预措施: Self-Control Training (Behavioral)
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.
干预措施: Use of Educational Resources (Behavioral)
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.
干预措施: Cardiac Rehabilitation Program (Other)
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.
干预措施: Cardiac Rehabilitation Program (Other)
结局指标
主要结局
Cardiac Self-Efficacy
时间窗: 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
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
次要结局
- 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)
- Lipid Profile(Experimental Group: Baseline and 8 months Control Group: 8 months only)
- Cardiac Rehabilitation Adherence(8 months (for both groups))
研究者
Sergio Mies Padilla
Nurse doctor in the research support unit
Servicio Canario de Salud