Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07402642
Enrollment
256
Registered
2026-02-11
Start date
2026-01-12
Completion date
2027-01-01
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Patient Education, Secondary Prevention, Nursing Care, Self Efficacy, risk factors, Healthy Lifestyle, Cardiovascular Diseases

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.

Interventions

BEHAVIORALTherapeutic Adherence Reinforcement

Continuous education and monitoring to ensure compliance with the prescribed pharmacological plan

BEHAVIORALSelf-Control Training

Training the patient for autonomous monitoring of risk factors, such as blood pressure

BEHAVIORALUse of Educational Resources

Provision of adapted materials (infographics and written documents) to permanently reinforce healthy knowledge and behaviors

BEHAVIORALMotivational and Individualized Interviewing

Used to verify the patient's understanding of their condition and to motivate behavioral changes.

BEHAVIORALHeart-Healthy Dietary Education

Specific counseling to improve adherence to the Mediterranean diet and address overweight or obesity

BEHAVIORALTobacco Cessation Approach

Interventions aimed at increasing motivation to quit smoking and reducing nicotine dependence

Personalized exercise recommendations tailored to the patient's clinical status

BEHAVIORALEmotional Health Management

Professional support to address emotional well-being, detecting potential states of anxiety or depression following the acute event.

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.

Sponsors

Sergio Mies Padilla
Lead SponsorOTHER
Complejo Hospitalario Universitario Insular Materno Infantil
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The study model designed for your research is defined as a quasi-experimental parallel group trial. In this design, participants are divided into two branches that progress simultaneously but independently, receiving different levels of care. Experimental Group (Prospective Recruitment): participants receive standard medical care plus a structured, protocol-based nursing consultation. Control Group (Retrospective Recruitment): participants receive standard care only, which includes the conventional cardiac rehabilitation program

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Self-EfficacyExperimental 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 standardHis 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

Secondary

MeasureTime frameDescription
Cardiac Rehabilitation Adherence8 months (for both groups)Exploration of patient inclusion, adherence (number of sessions attended), and group education received
Adherence to the Mediterranean DietExperimental Group: baseline and 8 months Control Group: 8 months onlyMeasured using the MEDAS questionnaire (14 items). Higher scores indicate greater adherence to a heart-healthy diet
Nicotine DependenceExperimental Group: baseline and 8 months Control Group: 8 months onlyAssessed using the Fagerström Test (6 items). Scores range from 0 to 10, where greater than or equal to 7 indicates high dependence
Motivation to Quit SmokingExperimental Group: Baseline and 8 months . Control Group: 8 months only.Evaluated through the Richmond Test (4 items). Scores range from 0 to 10; scores between 8-10 indicate high motivation.
Physical Activity LevelExperimental Group: Baseline and 8 months Control Group: 8 months only.Measured using the International Physical Activity Questionnaire (IPAQ). It categorizes patients into high, moderate, or low activity levels based on METs.
Lipid ProfileExperimental Group: Baseline and 8 months Control Group: 8 months onlyClinical data collection of total cholesterol, LDL, HDL, and triglycerides from medical records
Affective State (Anxiety and Depression)Experimental Group: Baseline and 8 months Control Group: 8 months onlyDetermined using the Goldberg Scale. It consists of two subscales (anxiety mayor o igual a 4 and depression greater than or equal to 2) to detect psychological distress

Countries

Spain

Contacts

CONTACTSergio Mies Padilla
smiepad@gobiernodecanarias.org+34928478880
CONTACTCristina María Torres Moreno
isocrimi@gmail.com+34928444000 (ext:71363)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026