selective prevention of cardiovascular disease witH panElmAnagement and integrated LifeSTYlE inTervention in primARy care (HEALThY HEARt)
- Conditions
- Cardiovascular diseases1008220610047066
- Registration Number
- NL-OMON45708
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1600
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients must be registered at primary care practices connected to ELZHA.
- Patients must be identified as high risk patients, which corresponds to a 10-year cardiovascular risk of *10% according to Dutch guidelines.
For the selection of high risk patients the following ICPC codes will be used, namely hypertension uncomplicated (K86), hypertension complicated (K87) and lipid disorder (T93). In addition, the following ATC codes will be used, namely cardiac therapy (C01), antihypertensive drugs (C02), diuretic drugs (C03), peripheral vasodilators (C04), vasoprotective drugs (C05), beta blocking agents (C07), calcium channel blockers (C08), agents acting on the renin-angiotensin system (C09) and lipid modifying agents (C10).
- Patients must be capable of giving informed consent (IC).;Primary care practices connected to ELZHA are eligible to participate in this study if data on blood pressure, fasting serum lipid profile and smoking status are accessible through patient records in at least 70% of their high risk population.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who have an ICPC coded diagnosis of cardiovascular disease will be excluded.
For the exclusion of CVD patients the following ICPC codes will be used, namely ischemic heart disease with angina pectoris (K74), acute myocardial infarction (K75), ischemic heart disease without angina pectoris (K76), transient cerebral ischemia (K89), cerebral infarction (K90.03), intermittent claudication (K92.01) and aortic aneurysm (K99.01).
- Patients who have an ICPC coded diagnoses of diabetes mellitus (T90) will be excluded.
- Patients living in nursing homes will be excluded.
- Patients with dementia will be excluded.
- Patients with major comorbidity, for example patients who are terminally ill, will be excluded, based on judgment of the general practitioner.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is change of lifestyle (composite of: stopping smoking,<br /><br>reducing alcohol intake, improving diet, reducing overweight, increasing<br /><br>physical activity). </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary outcomes we aim to identify the most effective components of the<br /><br>program and effective components of implementation of the program in primary<br /><br>care. For these secondary outcome measures we will assess differences between<br /><br>primary care practices in high- and low socioeconomic areas and between<br /><br>participants with western and non-western ethnicity. </p><br>