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selective prevention of cardiovascular disease witH panElmAnagement and integrated LifeSTYlE inTervention in primARy care (HEALThY HEARt)

selective prevention of cardiovascular disease witH panElmAnagement and integrated LifeSTYlE inTervention in primARy care (HEALThY HEARt) - Healthy Heart

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45708
Enrollment
1600
Registered
2017-06-13
Start date
2017-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular diseases

Interventions

In this project we evaluate two prevention strategies (individual and group-based) in a real-life primary care setting. Based on shared-decision-making patients proceed with usual preventive care or
Cardiovascular disease
Lifestyle intervention
Prevention
Primary care

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The primary outcome is change of lifestyle (composite of: stopping smoking, reducing alcohol intake, improving diet, reducing overweight, increasing physical activity).

Secondary

MeasureTime frame
As secondary outcomes we aim to identify the most effective components of the program and effective components of implementation of the program in primary care. For these secondary outcome measures we will assess differences between primary care practices in high- and low socioeconomic areas and between participants with western and non-western ethnicity.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)