An interventional study of EDUCORE intervention and Control group in Hypertension, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 2 sites in Spain. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Prevention
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 452 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Gerencia de Atención Primaria, Madrid is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Use of low risk SCORE table; verbally informing the patient of his/her CVR. Giving advice/verbal information on risk factors.
Other: Control group
Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients
SCORE oral information and counseling as standard practice care
Main outcome variable: control of blood pressure
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
Time frame: Baseline and 1 year
Cardiovascular risk (CVR) level : Use of low risk SCORE table
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.
Time frame: Baseline and 1 year
Measure of Adherence to treatment (Morisky-Green questionnaire)
therapeutic compliance (measured using the Morisky-Green treatment compliance questionnaire)
Time frame: 1 year
Smoking habits
Use of tobacco
Time frame: Baseline and 1 year
Total Cholesterol
Total cholesterol level
Time frame: Baseline and 1 year
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid