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

NCT01155973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2018-02-23

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

EDUCORE intervention

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

OTHER

Control group

SCORE oral information and counseling as standard practice care

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Gerencia de Atención Primaria, Madrid

    lead OTHER_GOV

Principal Investigators

  • Esperanza Escortell, MD · Gerencia de Atención Primaria, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01155973 on ClinicalTrials.gov