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

NCT01155973 | Completed DMC

• 1 other identifier: 09/90354
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

Hypertension.; Cardiovascular risk.; Monitoring.; Primary health care.; Randomised controlled trial.; Cluster analysis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 1 year

Secondary Outcomes (4)

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

  Baseline and 1 year

• Measure of Adherence to treatment (Morisky-Green questionnaire)

  1 year

• Smoking habits

  Baseline and 1 year

• Total Cholesterol

  Baseline and 1 year

Study Arms (2)

EDUCORE intervention

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Use of low risk SCORE table; verbally informing the patient of his/her CVR. Giving advice/verbal information on risk factors.

Other: Control group

Interventions

EDUCORE intervention BEHAVIORAL

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

EDUCORE intervention

Control group OTHER

SCORE oral information and counseling as standard practice care

control group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes Mellitus
• Cardiovascular disease...

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (2)

Gerencia de Atención Primaria, Madrid

Madrid, 28035, Spain

Location

Gerencia de Atención Primaria, Madrid

Madrid, Spain

Location

Related Publications (2)

• 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.

  PMID: 20673325 BACKGROUND

• 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.

  PMID: 34693994 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Esperanza Escortell, MD

  Gerencia de Atención Primaria, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 2, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

ES (2)