Open Access Study protocol

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

Isidro Rodríguez-Salceda1, Esperanza Escortell-Mayor2*, Milagros Rico-Blázquez3, Rosario Riesgo-Fuertes4, Angel Asúnsolo-del Barco5, Antonio Valdivia-Pérez6, Isabel del Cura-González7, Ana B García-Cañón8, María F Ortiz-Jiménez9, Luisa Cabello-Ballesteros10, Sofia Garrido-Elustondo11, Laura Chamorro-González12, Ricardo Rodríguez-Barrientos13 and the EDUCORE Group14

Author Affiliations

1 Centro de Salud de Veredillas, Atención Primaria Área 3, Servicio Madrileño de Salud, Torrejón de Ardoz (Madrid), Spain

2 Gerencia Atención Primaria Área 3, Servicio Madrileño de Salud, Alcalá de Henares (Madrid), Spain

3 Dirección General de Atención Primaria de Madrid, Servicio Madrileño de Salud, Madrid, Spain

4 Gerencia Atención Primaria Área 1, Servicio Madrileño de Salud, Madrid, Spain

5 Universidad de Alcalá, Alcalá de Henares (Madrid), Spain

6 Unidad de Medicina Preventiva, Hospital de Denia, Marina Salud, Agéncia Valenciana de Salut, Denia (Alicante), Spain

7 Gerencia Atención Primaria Área 9, Servicio Madrileño de Salud, Leganés (Madrid), Spain. Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Madrid, Spain

8 Unidad de Apoyo a la Investigación Clínica y Ensayos Clínicos en Atención Primaria (CAIBER), Área de Investigación, Agencia Laín Entralgo, Consejería de Sanidad, Comunidad de Madrid, Madrid, Spain

9 Centro de Salud Puerta de Madrid, Atención Primaria Área 3, Servicio Madrileño de Salud, Alcalá de Henares, Madrid, Spain

10 Gerencia Atención Primaria Área 10, Servicio Madrileño de Salud, Getafe (Madrid), Spain

11 Gerencia Atención Primaria Área 7, Servicio Madrileño de Salud, Madrid, Spain

12 Hospital Universitario de Getafe, Servicio Madrileño de Salud, Getafe (Madrid), Spain

13 Gerencia Atención Primaria Área 5, Servicio Madrileño de Salud, Madrid, Spain

14 Servicio Madrileño de Salud (Atención Primaria), Comunidad de Madrid, Madrid, Spain

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BMC Public Health 2010, 10:449  doi:10.1186/1471-2458-10-449

Published: 30 July 2010

Abstract

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 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 cardiovascular risk 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;

Methods/Design

This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, 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;

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;

Trial registration

The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov webcite].