Educore Project: Effect of a Visual Learning Method for Improving Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Background: High blood pressure (HBP) is a major risk factor for cardiovascular disease
      (CVD). European hypertension and cardiology societies as well as expert committees on CVD
      prevention recommend stratifying cardiovascular risk (CVR) using the SCORE 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 determine whether the use of
      a CVR visual learning method - the EDUCORE method - is more effective than normal clinical
      practice in improving the control of blood pressure within one year in patients with poorly
      controlled hypertension but no background of CVD.

      Design & Method: Cluster randomized controlled clinical trial. 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. Measurements: Outcome variables: systolic and diastolic blood pressure (mmHg).
      Cardiovascular risk level: SCORE. Measure of Adherence to treatment (Morisky-Green
      questionnaire. Health related quality of life questionnaire MINICHAL. Smoking habits. Total
      Cholesterol. Other variables: Gender. Age. Educational level. Physical activity in metabolic
      equivalent (MET). Body mass index. Drug consume (cardiovascular line). Treatment changes and
      nature of the change. Intervention: EDUCORE group (direct exhibition of their cardiovascular
      risk with SCORE, visual images and documentation to the patients); Control Group: standard
      practice care.
    

Detailed description: 
      Aim: To measure the effectiveness of an educational intervention in uncontrolled hypertensive
      patients without cardiovascular disease (primary prevention), compared with clinical practice
      to improve hypertension control in a year.

      Method: This work describes a protocol for a clinical trial, randomised by clusters and
      involving 22 primary healthcare clinics (PHCC), to test the effectiveness of the EDUCORE
      method. The number of patients required was 736, all between 40 and 65 years of age (n=368 in
      the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year
      ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg
      and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained
      in its methodology. 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. The main outcome variable was the
      control of blood pressure; secondary outcome variables included the SCORE score, therapeutic
      compliance, quality of life, and total cholesterol level. All outcome variables were measured
      at the beginning of the experimental period and again at 6 and 12 months. Information on sex,
      age, educational level, physical activity, body mass index, consumption of medications,
      change of treatment and blood analysis results was also recorded.

      Information source: Clinical interview and assessments tests. The data will be registered in
      Electronic data capture system.

      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.
    

Intervention name(s): EDUCORE intervention; Control group
Intervention type(s): Behavioral; Other
Intervention description(s): Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients; SCORE oral information and counseling as standard practice care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension.; Cardiovascular risk.; Monitoring.; Primary health care.; Randomised controlled trial.; Cluster analysis