The primary goals of this project are to 1) evaluate the effectiveness, 2) identify effective elements and 3) find successful implementation factors of an integrated group-based lifestyle intervention programme in primary care.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is change of lifestyle (composite of: stopping smoking,
reducing alcohol intake, improving diet, reducing overweight, increasing
physical activity).
Secondary outcome
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.
Background summary
Cardiovascular disease (CVD) is among the most frequent chronic diseases in the
Netherlands. So, prevention is of high importance and primary care could play
an important role. The cornerstone of CVD prevention is lifestyle change.
However, knowledge on effectiveness and implementation of lifestyle
intervention programmes in primary care is scarce. This project adds valuable
knowledge of effect and successful implementation of integrated lifestyle
intervention in primary care.
Study objective
The primary goals of this project are to 1) evaluate the effectiveness, 2)
identify effective elements and 3) find successful implementation factors of
an integrated group-based lifestyle intervention programme in primary care.
Study design
Using a stepped-wedge design we will assess effectiveness. The implementation
will be evaluated with mixed-methods design. High risk patients (n=1600) are
identified and followed with a panelmanagement method.
Intervention
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 follow
the integrated group-based lifestyle program.
Study burden and risks
High risk patients are invited for a consultation in their primary care
practice and are offered the integrated group-based intervention. Based on
shared-decision-making patients proceed with usual preventive care or follow
the integrated group-based lifestyle program. Usual preventive care consists of
one to four consultations during one year with a primary care nurse,
specialized in cardiovascular care and trained for lifestyle education.
Patients who choose to follow the group-based lifestyle program, attend seven
to ten group sessions during 4 to 6 months in groups of 10 persons. During the
group sessions, all aspects of lifestyle change (smoking, alcohol intake, diet,
overweight, physical activity) are discussed by a lifestyle coach. Using
questionnaires at baseline and at the end of the intervention (usual preventive
care or the integrated group-based lifestyle program), we will asses change of
lifestyle. Furthermore, all eligible patients will be asked to complete a
questionnaire about barriers and facilitators to participation in this project.
Routine care data will be used to compare blood pressure and cholesterol levels
between patient groups.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
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
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60795.058.17 |