The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study (ZWOT-CASE)

UMC Utrecht

Status: Unknown

Conditions: Hypertension; Hypercholesterolemia; Cardiovascular Diseases

Treatments: Other: Integrated care for cardiovascular risk management

Study type: Observational

Funder types: Other

Identifiers

NCT03428061

57867

Details and patient eligibility

About

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.

Enrollment: 740 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

740 participants in 2 patient groups

Intervention group

Description:

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.

Treatment:

Other: Integrated care for cardiovascular risk management

Control group

Description:

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.