Randomized clinical trial to assess the efficacy of an intervention to reduce the cardiovascular risk by improving the information given to patients

• Register: ISRCTN
• Last refreshed on: 28 June 2021
• Main ID: ISRCTN18383298
• Date of registration: 06/02/2018
• Prospective Registration: No
• Primary sponsor: Biomedical Research Institute Sant Pau
• Public title: Randomized clinical trial to assess the efficacy of an intervention to reduce the cardiovascular risk by improving the information given to patients
• Scientific title: Multicentre, randomised, open clinical trial to assess the efficacy of an intervention to reduce the cardiovascular risk by improving the information given to patients at high cardiovascular risk
• Date of first enrolment: 01/10/2016
• Target sample size: 1256
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN18383298
• Study type: Interventional
• Study design: Multicentre randomised controlled open clinical trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Carlos Brotons

Key inclusion & exclusion criteria

Inclusion criteria:
1. Both gender
2. 40- 69 years old
3. Fulfilling at least one of the following criteria
3.1. High cardiovascular risk (SCORE =5% and/or REGICOR =10%)
3.2. SCORE relative risk >= 4
3.3. Diabetes with proteinuria or a major risk factor (smoking, dyslipidaemia or hypertension)
4. Severe kidney chronic disease (GFR < 30 mL/min/1.73 m2)
5. Subclinical Atherosclerosis

Exclusion criteria:
1. Patients with established cardiovascular disease
2. Life expectancy of less than 1 year
3. Mental disease limiting patient’s self-care capability
4. Drug and/or alcohol abuse
5. Already enrolled in another clinical trial


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

People at high cardiovascular risk
Circulatory System
High cardiovascular risk

Intervention(s)

The intervention consists of explaining cardiovascular risk in a more comprehensive way including figures, in terms of absolute risk, relative risk and vascular age.

Randomization (1: 1 ratio) is done through an electronic system that assigns the subjects in each group (intervention or control).

Intervention arm: Cardiovascular risk estimation is explained by a research nurse in a more understandable manner, using not only absolute risk, but also relative risk as well as the vascular age, with different figures. Cardiovascular estimation is done using European SCORE as well as Regicor tool. The programme is mainly focused on changing unhealthy habits, such as tobacco, sedentarism, and diet. Compliance to medication is reinforced, and control of blood pressure and lipids are monitored, with adjustement of medication if needed. Patients are visited every three months, and two telephone calls are done between each visit to reinforce changes.

Control arm: Participants are visited once at the beginning in order to register healthy habits and risk factors, and cardiovascular risk is estimated. They are then follow by their GPs as usual care.

Participants are visited every three months to monitor changes in healthy habits, risk factors, and pharmacological treatment, and reinforce the concept of cardiovascular risk.

Patients from both arms are visited again at one year (last visit) to be assessed in terms of cardiovascular risk. Blood pressure and blood cholesterol is measured as the beginning and at the end of the study.

Primary Outcome(s)

Cardiovascular risk is measured using the SCORE system as well as REGICOR tool at baseline and at one-year, at the end of the trial

Secondary Outcome(s)

1. Physical exercise is measured using IPAQ (International Physical Activity questionnaire) at baseline and at the end of the trial
2. Diet is measured using Mediterranean Diet Score at baseline and the end of the trial
3. Tobacco measured using a specific questionnaire collecting information on number of cigarrtes at baseline and at the end of the trial
4. Blood lipids are measured using blood tests at baseline and at the end of the trial
5. Blood pressure is measured using a semi-automatic digital blood pressure monitor at baseline and at the end of the trial
6. Weight is measured using a digital weighing scale at baseline and at the end of the trial
7. BMI is measured using heght and weight (Kg/m2) at baseline and at the end of the trial

Secondary ID(s)

SLT002/16/00313

Source(s) of Monetary Support

Generalitat de Catalunya (Catalan Health Department)

Ethics review

Status:
Approval date:
Contact:

IDIAP Ethics Committee, 09/05/2017, ref: ref: P17/093

Results

• Results available: Yes
• Date Completed: 31/12/2019