Abstract:

Health education is one of the main tools to use in primary care to achieve changes on unhealthy habits. It is important to determine the effectiveness of educational measures that apply in everyday practice. To do this we have designed a multicenter clinical trial in Madrid.

High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD), which effect on mortality is enhanced by other factor related to lifestyles. European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE (Systematic Coronary Risk Evaluation) method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors.

The EDUCORE (Education and Coronary Risk Evaluation) project aims to measure the effectiveness of a cardiovascular risk visual learning method – the EDUCORE method - in uncontrolled hypertensive patients without cardiovascular disease (primary prevention), compared with normal clinical practice to improve the control of blood pressure within one year.

Design & Method: Cluster randomised controlled clinical trial. The trial was registered as NCT01155973 [ClinicalTrials.gov Identifier: http:// ClinicalTrials.gov]. The actual patient recruitment started on June 1st, 2010. Location: 22 primary health care centres in Madrid. Participants: patients diagnosed as hypertensive (systolic >140 mmHg and/or diastolic >90 mmHg) at least a year before, uncontrolled. Age: 40-65 year-old patients who consent to take part. Sampling: randomized cluster assignment. Random allocation unit: health care centre. Analysis unit: patient who match criteria. Size: 736 patients (368 each arm. Information source: Clinical interview and assessments tests. The data will be registered in Electronic data capture system. Measurements. Main outcome variable: control of blood pressure. Secondary outcome variables: SCORE score, therapeutic compliance, quality of life, Smoking habits and total cholesterol level. Other variables: Gender. Age. Educational level. Physical activity. Body mass index. Drug consume (cardiovascular line). Treatment changes and blood analysis results. Planning: at the beginning of the experimental period and again at 6 and 12 months.
Intervention: The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. Control Group: standard practice care. Statistical Analysis: Primary and secondary effectiveness. Adjusting by prognosis factors with random effects models (logistic regression) (dependent variable: good/bad blood pressure control; independent variable: intervention group).

Discussion: The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting. Clinical trials are feasible studies to test the effectiveness of health education methods on health outcomes.
This study has been funded by the Instituto de Salud Carlos III, Science & Innovation Ministry (09/90354; Madrid. Spain). Project approved by an ethical review board (Comité de Ética de Investigación Clínica, CEIC - Hospital Universitario Príncipe de Asturias, Madrid).

Keywords:

Educational intervention, Primary health care, Hypertension, Cardiovascular risk, Randomized controlled trial.