Cardiovascular disease, prevention, lifestyle intervention
Conditions
Interventions
In this project we evaluate two prevention strategies (individual usual care and a group-based lifestyle program) in a real-life primary care setting, using a stepped-wedge observational cohort design
Sponsors
Leiden University Medical Center
Primary Care Group The Hague (ELZHA)
Eligibility
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 Primary Care Group The Hague (ELZHA; Eerstelijns Zorggroep Haaglanden). - 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 (CO2), diuretic drugs (CO3), peripheral vasodilators (C04), vasoprotective drugs (G05), beta blocking agents (C07), calcium channel blockers (C08), agents acting on the renin-angiotensin system (C09) and lipid modifying agents (G10). - 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
| Measure | Time frame |
|---|---|
| Primary outcome is the difference in mean proportion of achievement of individual lifestyle goals between the control group (all patients during usual preventive care) and the intervention group (all patients during combined usual preventive care and group-based intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes we will evaluate change of lifestyle (composite of: stopping smoking, reducing alcohol intake, improving diet, reducing overweight, increasing physical activity) and compliance to (Dutch) lifestyle guidelines. Furthermore, we aim to identify the most effective components of the program and effective components of implementation of the program in primary care. Other secondary outcomes include quality of life, self-efficacy, cost-effectiveness of the integrated lifestyle program and treatment effects on blood pressure and cholesterol levels. 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. Lastly, we want to assess food security status to assess the degree of food security. Further, we want to assess associations between risk factors for cardiovascular diseases and food security status, and the association between setting individual lifestyle goals and food security status. | — |
Contacts
Public ContactS.M. Verkleij
Afdeling Public Health & Eerstelijnsgeneeskunde Leids Universitair Medisch Centrum, Postzone VO-P
Outcome results
None listed