HypertensionEDUCORENCT01155973
Educore Project: Effect of a Visual Learning Method for Improving Blood Pressure Control
A study testing EDUCORE intervention in people with Hypertension, run by Gerencia de Atención Primaria, Madrid at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- EDUCORE intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes Mellitus
- Cardiovascular disease...
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Gerencia de Atención Primaria, Madrid
Madrid, 28035
Gerencia de Atención Primaria, Madrid
Madrid
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- EDUCORE intervention, Control group
- Keywords
- Hypertension., Cardiovascular risk., Monitoring., Primary health care., Randomised controlled trial., Cluster analysis
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUCORE interventionBehavioural
Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients
Control groupOther
SCORE oral information and counseling as standard practice care
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 1 year
Secondary outcomes (4)
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.
Measured: Baseline and 1 year
Measure of Adherence to treatment (Morisky-Green questionnaire)
therapeutic compliance (measured using the Morisky-Green treatment compliance questionnaire)
Measured: 1 year
Smoking habits
Use of tobacco
Measured: Baseline and 1 year
Total Cholesterol
Total cholesterol level
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Esperanza Escortell, Gerencia de Atención Primaria, Madrid
- Investigators
- Esperanza Escortell, MD, Principal investigator, Gerencia de Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155973
- Sponsor's protocol ID
- 09/90354
- Acronym
- EDUCORE
- Status last verified
- Feb 2018
- First submitted
- 29 Jun 2010
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20673325Lindson 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.
PubMed 34693994
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01155973
- Acronym / sponsor ID
- EDUCORE / 09/90354
- Conditions
- Hypertension
- Keywords
- Hypertension., Cardiovascular risk., Monitoring., Primary health care., Randomised controlled trial., Cluster analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDUCORE intervention | Experimental | Behavioral: EDUCORE interventionUse 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). |
| control group | Active comparator | Other: Control groupUse of low risk SCORE table; verbally informing the patient of his/her CVR. Giving advice/verbal information on risk factors. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diabetes Mellitus
- Cardiovascular disease...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDUCORE interventionDirect exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients | Behavioural | EDUCORE intervention |
| Control groupSCORE oral information and counseling as standard practice care | Other | control group |
Primary outcome
Main outcome variable: control of blood pressure
Time frame: Baseline and 1 year
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
4 secondary outcomes
Cardiovascular risk (CVR) level : Use of low risk SCORE table
Time frame: Baseline and 1 year
Measure of Adherence to treatment (Morisky-Green questionnaire)
Time frame: 1 year
Smoking habits
Time frame: Baseline and 1 year
Total Cholesterol
Time frame: Baseline and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 20673325Rodriguez-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.
- Derived from this study: PubMed 34693994Lindson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esperanza Escortell, MD principal investigator
Gerencia de Atención Primaria, Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDUCORE intervention in people with Hypertension, run by Gerencia de Atención Primaria, Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome variable: control of blood pressure (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.