Improving lifestyle adherence in patients with high risk of cardiovascular diseases in General Practice.

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN51556722
• Lead Sponsor: The Research Institute of the University Maastricht (CAPHRI) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Current inclusion criteria as of 28/08/2007:
Preferably patients:
1. With high blood pressure: greater than or equal to 140 mmHg or already treated for it
2. With high total cholesterol: greater than or equal to 6.5 mmol/l or already treated for it
3. Who are smoking (men greater than or equal to 50 years, women greater than or equal to 55 years)
4. With diabetes

Next to it patients with:
1. Positive family history of CVD
2. Visible obesity

Explanation for change to inclusion and exclusion criteria as of 28/08/2007:
On January 1 2006, the Dutch Institute for Health Care Improvement (CBO) published the Dutch national guideline for Cardiovascular Risk Management, in close collaboration with the Dutch College of General Practitioners (NHG). The indications for a cardiovascular risk assessment were clearly described in the guideline, and we decided to use these indications as inclusion criteria because the GPs and practice nurses had to work with this guideline. We excluded patients with existing cardiovascular diseases. Following the new guideline, these patients are at high risk and the risk table, which is a part of our intervention, is not applicable anymore for these patients. We expected no problems for the inclusion, because we had planned to recruit 20 general practices in our trial but we had such a great response on our recruitment (40 practices were willing) that we decided to let 25 practices participate. The number of patients that each practice had to include was the same as before.

Previous inclusion criteria:
1. Patients aged 40 - 70 years without cardiovascular diseases (CVD) but with an absolute cardiovascular risk of greater than 20% in 10 years
2. Patients younger then 40 years without CVD, but with an extrapolated high estimation of their risk at an age of 60 due to modifiable lifestyle factors
3. Diabetes mellitus patients
4. Patients with established CVD

Exclusion Criteria

Current exclusion criteria as of 28/08/2007:
1. Cardiovascular patients or diabetes patients who are primarily managed in secondary care (eg by cardiologist or internist, in rehabilitation programme)
2. Patients at high-risk based on Familial Hypercholesterolaemia only
3. Patients with existing CVD

Explanation for change to inclusion and exclusion criteria can be found above.

Previous exclusion criteria:
1. Cardiovascular patients or diabetes patients who are primarily managed in secondary care (eg by cardiologist or internist, in rehabilitation programme)
2. Patients at high-risk based on Familial Hypercholesterolaemia only

Study & Design

• Study Type: Interventional
• Study Design: Not specified