The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

Study Overview
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Brief Summary
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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.

Official Title
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The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

Conditions
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Cardiovascular Diseases, Hypercholesterolemia, Hypertension

Intervention / Treatment
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* Other: Integrated care for cardiovascular risk management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for patients with CVD: Patients with a history of atherosclerotic CVD defined as documented angina pectoris, myocardial infarction, chronic ischemic heart disease, coronary sclerosis, transient ischaemic attack (TIA), cerebral infarction, intermittent claudication or aneurysm of the abdominal aorta The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist Age between 40 and 80 years Inclusion criteria for high risk patients: Use of blood pressure lowering or lipid lowering drugs A 10 -years CV risk > 10%, based on the Dutch guideline for CVRM and i) either 1 strongly cardiovascular risk enhancing factor or 2 mildly cardiovascular risk enhancing factors (see table 6) or ii) > 1 CV risk factor (current smoking, SBP>140 mmHg, LDL>2.5 mmol/L, TC/HDL-ratio > 8, chronic renal impairment (age < 65 years: eGFR < 60 ml/min/1,73 m2; age ≥ 65 years: eGFR < 45 ml/min/1,73 m2, and/or (micro)albuminuria). A 10-year CV risk of >20% and > 1 CV risk factor (current smoking, SBP>140 mmHg, LDL>2.5 mmol/L, TC/HDL-ratio > 8, chronic renal impairment (age < 65 years: eGFR < 60 ml/min/1,73 m2; age ≥ 65 years: eGFR < 45 ml/min/1,73 m2, and/or (micro)albuminuria). The CV risk of the patient is managed in primary care, not in the hospital or outpatient clinic by a medical specialist Age between 40 and 80 years Exclusion criteria for all patients: Diabetes mellitus, as these patients are already included in a disease management program for diabetes mellitus Limited life expectancy, as assessed by the GP Cognitive impairment, as assessed by the GP No Dutch language proficiency Staying abroad for longer than three months during the duration of the study. The CV risk of the patient is managed in the hospital or outpatient clinic by a medical specialist

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>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. | Other: Integrated care for cardiovascular risk management<br>* Disease management program for the prevention of cardiovascular diseases<br>|
| Control group<br>Usual care will be based on the Dutch CVRM guideline, describing how to calculate the CVR and advices to lower this risk by lifestyle intervention and/or medication. However systematic identification of patients eligible for CVRM, actively inviting patients for a visit, regular follow-up and standardized collaboration with other disciplines in the health care chain are not necessarily part of usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure, manual or electronic oscillometric measurement, at least 2 measurements with an interval of 1-2 minutes | After 1 year of follow-up | 
| LDL-cholesterol | Blood sample | After 1 year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-years cardiovascular morbidity or mortality risk | 10-years cardiovascular morbidity or mortality risk (percentage) (Risk chart Dutch guideline or SMART risk score) | After 1 year of follow-up | 
| Smoking status | Smoking yes or no | After 1 year of follow-up | 
| Body mass index (BMI) | 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 | After 1 year of follow-up | 
| Healthy diet | 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. | After 1 year of follow-up | 
| Physical activity | Squash questionnaire | After 1 year of follow-up | 
| Motivation to quit smoking | Motivation to quit smoking: motivated to quit/not motivated to quit/ considers to quit smoking | After 1 year of follow-up | 
| Awareness of received lifestyle advices | Aware/ not aware of received lifestyle advices, measured by questionairre | After 1 year of follow-up | 
| Awareness of food habits | Patient will be asked whether he/she thinks if he/she has healthy food habits yes or no. Measured by a questionairre | After 1 year of follow-up | 
| Awareness of physical activity | 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 | After 1 year of follow-up | 
| Awareness of weight | Patient will be asked whether he/she thinks if he/she has a healthy weight yes or no. Measured by a questionairre | After 1 year of follow-up | 
| Awareness of hyperlipidaemia | Patient will be asked whether he/she thinks if he/she has hyperlipidaemia yes or no. Measured by a questionairre | After 1 year of follow-up | 
| Awareness of cardiovascular disease risk | Estimation by patient of his/her own cardiovascular disease risk by a questionairre | After 1 year of follow-up | 
| Awareness of hypertension | Patient will be asked whether he/she thinks if he/she has hypertension yes or no. Measured by a questionairre | After 1 year of follow-up | 
| Use of adequate antihypertensives | Use of adequate antihypertensives according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice | After 1 year of follow-up | 
| Use of adequate lipid lowering drugs | 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 | After 1 year of follow-up | 
| Use of adequate anticoagulants | Use of adequate anticoagulants according to Dutch guideline for cardiovascular risk management. Measured by medication registered in electronic medical records in general practice | After 1 year of follow-up | 
| Morbidity | Newly developed cardiovascular diseases | After 1 year of follow-up | 
| Newly developed diabetes mellitus | Newly developed diabetes mellitus, based on coded diagnosis in electronic medical record in general practice | After 1 year of follow-up | 
| Newly developed COPD | Newly developed COPD, based on coded diagnosis in electronic medical record in general practice | After 1 year of follow-up | 
| Newly developed heart failure | Newly developed heart failure, based on coded diagnosis in electronic medical record in general practice | After 1 year of follow-up | 
| Newly developed atrial fibrillation | Newly developed atrial fibrillation, based on coded diagnosis in electronic medical record in general practice | After 1 year of follow-up | 
| Mortality | Died due to cardiovascular disease or other cause | After 1 year of follow-up | 
| Primary treating practitioner in the context of cardiovascular risk management | General practitioner or medical specialist. | After 1 year of follow-up | 
| Health care consumption in the past year | Consultations in the contect ox cardiovascular risk management in general practice | After 1 year of follow-up | 
| Self-management in the past year | Patient Activity Measure (PAM) | After 1 year of follow-up | 
| Self-measurements of blood pressure in the past year | Self-measurements of blood pressure in the past year yes or no | After 1 year of follow-up | 
| Patient satisfaction regarding the provided care in the past year | Patient Reported Experience Measure (PREM) | After 1 year of follow-up | 
| Quality of life | EQ-5D | After 1 year of follow-up | 
| Quality of life | SF-12 | After 1 year of follow-up | 
| Anxiety and depression | 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 | After 1 year of follow-up | 
| Cost-efficiency | iPCQ | After 1 year of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Disease Management, Integrated care, Primary Health Care