Cardiovascular prevention Circulatory System Cardiovascular prevention
Conditions
Interventions
1. The intervention group is provided with access to an interactive internet platform supported by a coach to facilitate and encourage self-management of risk factors and lifestyle change.
Sponsors
Academic Medical Centre Amsterdam (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 65 years 2. Available informant 3. = 2 cardiovascular risk factors and/or manifest cardiovascular disease defined as: 3.1. Cardiovascular risk factors: 3.1.1. Hypertension, defined by any of the following: 3.1.1.1. Diagnosis by specialist or GP 3.1.1.2. Currently on anti-hypertensive drugs 3.1.1.3. Baseline BP: if < 80 years: = 140/90 mmHg; if = 80 years: Systolic BP = 160 3.1.2. Dyslipidemia, defined by any of the following: 3.1.2.1. Diagnosis of dyslipidemia by specialist or GP 3.1.2.2. Use of lipid-lowering drug (this will include persons who have no dyslipidemia, but use it after a previous cardiovascular disease; this is acceptable, since these people automatically fulfil inclusion criteria as well) 3.1.2.3. Baseline total cholesterol = 5 mmol/L and/or LDL = 2.5 mmol/L 3.1.3. Overweight, defined by any of the following: 3.1.3.1. BMI = 30 3.1.3.2. Waist circumference men =102 cm, women =88 cm 3.1.4. Active smoking (self-reported, any tobacco use) 3.1.5. Lack of physical exercise (self-reported) defined as below the WHO norm of 30 minutes 5 times a week (or a total of 150 minutes per week) of intermediate exercise or 3.2. History of cardiovascular disease: 3.2.1. Stroke/transient ischemic attack (TIA) 3.2.2. Myocardial infarction 3.2.3. Angina pectoris 3.2.4. Peripheral arterial disease 3.2.5. Diabetes mellitus (DM)
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed dementia as diagnosed by a GP or specialist 2. Mini Mental State Examination score <24 3. Any condition expected to limit 18-months compliance and follow-up 4. Computer illiteracy, defined as unable to send an email and/or do a simple Google search 5. Severe visual impairment interfering with operating a computer 6. Participating in another randomised controlled trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is a weighted composite score based on z-scores of the difference between baseline and 18 months follow-up values of systolic blood pressure, cholesterol and BMI. The rationale behind this primary outcome is that: 1. 18-months follow-up is too short for a significant number of clinical outcome events even when using this sample size 2. Only measurable risk factors are included (self-reported factors such as physical exercise are sensitive to bias) 3. This will allow for very sensitive and direct assessment of the risk factors we target This has the potential caveat of making a type I error, but even a very small effect on cardiovascular risk profile could have considerable effect at the population level (prevention paradox). | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary outcomes are: 1. Z-scores of individual components of the primary outcome only in persons who have this risk score at baseline 2. Improvement in estimated 10-year cardiovascular disease risk based on the Framingham cardiovascular disease risk score (measured at 18 months) 3. Incident cardiovascular disease (stroke/TIA, myocardial infarction, peripheral arterial disease, heart failure) 4. Improvement of the number of measurable risk factors (blood pressure, BMI, cholesterol, glycated haemoglobin) 5. Improvement of the number of self-reported risk factors (physical exercise, diet) 6. Mortality 7. Disability 8. Cognitive decline 9. CAIDE dementia risk-score 10. Physical fitness (short physical performance battery) 11. Depression (15-item Geriatric Depression Scale) 12. Cost-effectiveness | — |
Countries
Finland, France, Netherlands
Outcome results
None listed