Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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.


Options:
A: Arm Label: COACH; Type: ACTIVE_COMPARATOR; Interventions: Other: COACH | Arm Label: Standard Care; Type: PLACEBO_COMPARATOR; Interventions: Other: No intervention for placebo | Intervention Type: OTHER; Name: COACH; Assigned to Arm(s): COACH | Intervention Type: OTHER; Name: No intervention for placebo; Assigned to Arm(s): Standard Care
B: Arm Label: EDUCORE intervention; Type: EXPERIMENTAL; Interventions: Behavioral: EDUCORE intervention | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Control group | Intervention Type: BEHAVIORAL; Name: EDUCORE intervention; Assigned to Arm(s): EDUCORE intervention | Intervention Type: OTHER; Name: Control group; Assigned to Arm(s): control group
C: Arm Label: High intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Low intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): High intensity intervention group, Low intensity intervention group
D: Arm Label: Information Support System; Type: EXPERIMENTAL; Interventions: Other: Information Support System | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Information Support System; Assigned to Arm(s): Information Support System

Answer: B