Clinical trial NCT01155973: Educore Project: Effect of a Visual Learning Method for Improving Blood Pressure Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension.
Cardiovascular risk.
Monitoring.
Primary health care.
Randomised controlled trial.
Cluster analysis
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Fondo de Investigacion Sanitaria
First posted: 2010-07-02
Enrollment: 452
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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...

Primary outcomes:
measure: Main outcome variable: control of blood pressure
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Cardiovascular risk (CVR) level : Use of low risk SCORE table
timeFrame: Baseline and 1 year
measure: Measure of Adherence to treatment (Morisky-Green questionnaire)
timeFrame: 1 year
measure: Smoking habits
timeFrame: Baseline and 1 year
measure: Total Cholesterol
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria, Madrid
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria, Madrid
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: Esperanza Escortell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Salceda I, Escortell-Mayor E, Rico-Blazquez M, Riesgo-Fuertes R, Asunsolo-del Barco A, Valdivia-Perez A, del Cura-Gonzalez I, Garcia-Canon AB, Ortiz-Jimenez MF, Cabello-Ballesteros L, Garrido-Elustondo S, Chamorro-Gonzalez L, Rodriguez-Barrientos R; EDUCORE Group. 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. BMC Public Health. 2010 Jul 30;10:449. doi: 10.1186/1471-2458-10-449.
citation: Lindson N, Pritchard G, Hong B, Fanshawe TR, Pipe A, Papadakis S. Strategies to improve smoking cessation rates in primary care. Cochrane Database Syst Rev. 2021 Sep 6;9(9):CD011556. doi: 10.1002/14651858.CD011556.pub2.