Highe risk of (recurrent) cardiovascular disease which is (partly) based on modifiable lifestyle-related risk factors.
Conditions
Interventions
The multi-faceted intervention for the intervention arm is meant to enhance patient involvement in decision making on cardiovascular risk management and comprises of:
1. Task delegation, cardiovascul
2. Two consultations, the first for risk presentation and communication, the second for discussion on objectives for risk reduction by lifestyle change or medical intervention. Each consultation will
Sponsors
Care and Public Health Research Institute (CAPHRI)
Department of General Practice
Maastricht University
PO Box 616
6200MD Maastricht
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 40-70 years without cardiovascular diseases (CVD) but with an absolute cardiovascular risk of >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
Exclusion criteria: 1. Cardiovascular patients or diabetes patients who are primarily managed in secondary care (e.g. by cardiologist or internist, in rehabilitation programme); 2. Patients at high-risk based on Familial Hypercholesterolaemia only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' adherence to lifestyle advice and drug treatment. Clinical endpoints will not be measured, but the absolute risk on cardiovascular events in 10 years will be estimated for each patient as a proxy measure for health gain. The 10-years absolute cardiovascular risk will be based on the current Dutch risk table, and on “HeartScore”, a risk table developed by the European Society of Cardiology. Specific behaviours related to smoking, diet, physical exercise, alcohol use and use of medication will be reported by patients, using validated self-reported questionnairesWe will use pedometers at T1 (12 weeks) to measure physical exercise during two weeks. Body mass index will be measured as a proxy-measure for healthy diet and exercise. Pill-count will be applied to validate the self-reported adherence to drugs. Data on the other risk factors will be derived from medical records in general practice (after informed consent by patients), and if absent or unreliable completed with additional data collection in patients. The primary behavioural outcome will be measured at T0 (baseline), T1 (12 weeks) and T2 (52 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Risk perception, anxiety, involvement and confidence in decision, attitudes, perceived social norms, self-efficacy, use of health care resources. Outcome for process evaluation: Key features of the intervention: 1st consultation- nurse explains risk by means of the risk communication tool to the patient- nurse explains options for risk reduction by lifestyle change to the patient- nurse hands over decision aid booklet + risk communication tool (for home work)2nd consultation- patient shows up for follow-up consultation- patient has prepared him or herself for the follow-up consultation- nurse checks the patient’s understanding of risk and options for risk reduction by lifestyle change- nurse applies motivational interviewing technique- nurse and patient agree on process of decision making- patient formulates, guided by the nurse, the main personal goal for lifestyle change (if applicable)extra items:- nurses’ attendance to the trianing, time needed per patient contact- time needed for discussing patients with the GP,- preferences for framing formats as expressed by the patients. The data for the process evaluation will be gathered by the nurse, by means of self-report. He or she will fill in a short standardised questionnaire after each consultation. Each item will be scored as a done/not done binary variable. If the score is ‘done’, the quality of the performance will be scored on a 5-point likert scale. | — |
Contacts
Public ContactM.S. Koelewijn
University Maastricht (UM), Department of General Practice, P.O. Box 61
Outcome results
None listed