The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study
- Conditions
- HypercholesterolemiaHypertensionCardiovascular Diseases
- Interventions
- Other: Integrated care for cardiovascular risk management
- Registration Number
- NCT03428061
- Lead Sponsor
- UMC Utrecht
- Brief Summary
Cardiovascular disease (CVD) contributes importantly to mortality and morbidity. Prevention of CVD by lifestyle change and medication is important and needs full attention.
In the Netherlands an integrated program for cardiovascular risk management (CVRM), based on the Chronic Care Model (CCM), has been introduced in many regions in recent years, but evidence from studies that this approach is beneficial is very limited.
In the ZWOT-CASE study the investigators will assess the effect of integrated care for CVRM in the region of Zwolle on two major cardiovascular risk factors: systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-cholesterol) in patients with or at high risk of CVD.
This study is a pragmatic clinical trial comparing integrated care for CVRM with usual care among patients aged 40-80 years with CVD (n= 370) or with a high CVD risk (n= 370) within 26 general practices. After one year follow-up, primary outcomes (SBP and LDL-cholesterol level) are measured. Secondary outcomes include lifestyle habits (smoking, dietary habits, alcohol use, physical activity), risk factor awareness, 10-year risk of cardiovascular morbidity or mortality, health care consumption, patient satisfaction and quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 740
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention group Integrated care for cardiovascular risk management The intervention under study will be the integrated care for cardiovascular risk management (CVRM), based on the Dutch CVRM guideline. Patients with a history of cardiovascular disease (CVD), a high cardiovascular risk (CVR) (\>10%) or use of antihypertensives or lipid lowering drugs are included in the program. Patients will be invited for an intake consultation, including a blood test, an interview, physical examination and estimation of the 10-years cardiovascular risk. If indicated, treatment with medication will be started and general lifestyle advises will be given. Patients can be referred to smoking cessation therapy, dietician and exercise programs or a physiotherapist. Patients will be controlled on a regular base to evaluate and adjust their personal goals.
- Primary Outcome Measures
Name Time Method Systolic blood pressure After 1 year of follow-up Systolic blood pressure, manual or electronic oscillometric measurement, at least 2 measurements with an interval of 1-2 minutes
LDL-cholesterol After 1 year of follow-up Blood sample
- Secondary Outcome Measures
Name Time Method Awareness of cardiovascular disease risk After 1 year of follow-up Estimation by patient of his/her own cardiovascular disease risk by a questionairre
Newly developed COPD After 1 year of follow-up Newly developed COPD, based on coded diagnosis in electronic medical record in general practice
Mortality After 1 year of follow-up Died due to cardiovascular disease or other cause
Primary treating practitioner in the context of cardiovascular risk management After 1 year of follow-up General practitioner or medical specialist.
Health care consumption in the past year After 1 year of follow-up Consultations in the contect ox cardiovascular risk management in general practice
Awareness of received lifestyle advices After 1 year of follow-up Aware/ not aware of received lifestyle advices, measured by questionairre
Awareness of food habits After 1 year of follow-up Patient will be asked whether he/she thinks if he/she has healthy food habits yes or no. Measured by a questionairre
Awareness of weight After 1 year of follow-up Patient will be asked whether he/she thinks if he/she has a healthy weight yes or no. Measured by a questionairre
Morbidity After 1 year of follow-up Newly developed cardiovascular diseases
Smoking status After 1 year of follow-up Smoking yes or no
Body mass index (BMI) After 1 year of follow-up The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. BMI will be measured by the general practitioner or practice nurse during the endpoint visit
Awareness of hyperlipidaemia After 1 year of follow-up Patient will be asked whether he/she thinks if he/she has hyperlipidaemia yes or no. Measured by a questionairre
Awareness of hypertension After 1 year of follow-up Patient will be asked whether he/she thinks if he/she has hypertension yes or no. Measured by a questionairre
Use of adequate lipid lowering drugs After 1 year of follow-up Use of adequate lipid lowering drugs according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Newly developed atrial fibrillation After 1 year of follow-up Newly developed atrial fibrillation, based on coded diagnosis in electronic medical record in general practice
Anxiety and depression After 1 year of follow-up Hospital Anxiety and Depression Scale (HADS), 0-7: no depression or anxiety, 8-10: depression or anxiety is possible,11-21: depression or anxiety is likely
10-years cardiovascular morbidity or mortality risk After 1 year of follow-up 10-years cardiovascular morbidity or mortality risk (percentage) (Risk chart Dutch guideline or SMART risk score)
Healthy diet After 1 year of follow-up Healthy diet yes or no according to the Dutch guideline for cardiovascular risk management and national guideline for healthy diet ((daily 150 - 200 grams vegetables and 200 grams fruit; daily 30 - 40 grams dietary fibers; twice a week 100 - 150 gram fish, at least once fatty fish; maximum of 6 grams salt per day; maximum of 2 (men) or 1 (women) alcohol consumptions per day). Food habits will be measured by a questionairre.
Motivation to quit smoking After 1 year of follow-up Motivation to quit smoking: motivated to quit/not motivated to quit/ considers to quit smoking
Awareness of physical activity After 1 year of follow-up Patient will be asked whether he/she thinks if he/she has a healthy level of physical activity yes or no. Measured by a questionairre
Patient satisfaction regarding the provided care in the past year After 1 year of follow-up Patient Reported Experience Measure (PREM)
Quality of life After 1 year of follow-up SF-12
Physical activity After 1 year of follow-up Squash questionnaire
Use of adequate antihypertensives After 1 year of follow-up Use of adequate antihypertensives according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Use of adequate anticoagulants After 1 year of follow-up Use of adequate anticoagulants according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice
Newly developed diabetes mellitus After 1 year of follow-up Newly developed diabetes mellitus, based on coded diagnosis in electronic medical record in general practice
Newly developed heart failure After 1 year of follow-up Newly developed heart failure, based on coded diagnosis in electronic medical record in general practice
Self-management in the past year After 1 year of follow-up Patient Activity Measure (PAM)
Self-measurements of blood pressure in the past year After 1 year of follow-up Self-measurements of blood pressure in the past year yes or no
Cost-efficiency After 1 year of follow-up iPCQ
Trial Locations
- Locations (1)
General Practices
🇳🇱Zwolle, Overijssel, Netherlands