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

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01155973
First received: June 29, 2010
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: EDUCORE intervention
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Main outcome variable: control of blood pressure [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cardiovascular risk (CVR) level : Use of low risk SCORE table [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]

    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.


  • Measure of Adherence to treatment (Morisky-Green questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Smoking habits [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
  • Total Cholesterol [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EDUCORE intervention
Use of low risk SCORE table. Use of visual impact images. Handing the patient a pamphlet (advice on how to maintain cardiovascular health plus the low risk SCORE table with the patient's current score marked).
Behavioral: EDUCORE intervention
Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients
Active Comparator: control group
Use of low risk SCORE table; verbally informing the patient of his/her CVR. Giving advice/verbal information on risk factors.
Other: Control group
SCORE oral information and counseling as 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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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...
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01155973

Locations
Spain
Servicio Madrileño de Salud
Madrid, Spain, 28033
Servicio Madrileño de Salud
Madrid, Spain
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Esperanza Escortell, MD Servicio Madrileño de Salud
  More Information

Additional Information:
Publications:
Responsible Party: Esperanza Escortell, Epidemiologist, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01155973     History of Changes
Other Study ID Numbers: 09/90354
Study First Received: June 29, 2010
Last Updated: April 3, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by Gerencia de Atención Primaria, Madrid:
Hypertension.
Cardiovascular risk.
Monitoring.
Primary health care.
Randomised controlled trial.
Cluster analysis

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014