Skip to main content
OpenTrials
Completed

NCT Number: NCT01155973

Educore Project: Effect of a Visual Learning Method for Improving Blood Pressure Control

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerencia de Atención Primaria, Madrid, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed as hypertensive (systolic >140 mmHg and/or diastolic >90 mmHg) at least a year before, uncontrolled.
  • Age: 40-65 year-old patients
  • Patients who consent to take part

Exclusion criteria

  • Diabetes Mellitus
  • Cardiovascular disease...

Treatment and study plan

EDUCORE intervention

Behavioral

Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients

Control Group

Other

SCORE oral information and counseling as standard practice care

Primary outcomes

  1. Main outcome variable: control of blood pressure

    Time frame: Baseline and 1 year

    Blood pressure (bp): systolic and diastolic blood pressure, determined using the Riva-Rocci method and listening for Korotkoff sounds, using validated and calibrated sphygmomanometers. Control BP: SBP < 140 mmHg and DBP < 90 mmHg

Secondary outcomes

  1. Cardiovascular risk (CVR) level : Use of low risk SCORE table

    Time frame: Baseline and 1 year

    Calculation of CVR at appointments 1, 3 and 5 (at the beginning of the experimental period and again at 6 and 12 months).

    Calculation of the projected CVR at 60 years of age for all patients under this age.

  2. Measure of Adherence to treatment (Morisky-Green questionnaire)

    Time frame: 1 year

    therapeutic compliance (measured using the Morisky-Green treatment compliance questionnaire)

  3. Smoking habits

    Time frame: Baseline and 1 year

    Use of tobacco

  4. Total Cholesterol

    Time frame: Baseline and 1 year

    Total cholesterol level

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

  • Fondo de Investigacion Sanitaria
  • Instituto de Salud Carlos III

Registry information

Official study title

Educore Project: A Clinical Trial, Randomised by Clusters, to Assess the Effect of a Visual Learning Method on Blood Pressure Control in the Primary Health Care Setting

Acronym: EDUCORE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2010
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.