The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

Hypertension Clinical Trial

— ZWOT-CASE  

Official title:

The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03428061
• Other study ID #: 57867
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 26, 2018
• Last updated: February 4, 2018
• Start date: September 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: February 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 740
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertension

Intervention

Other:
• Integrated care for cardiovascular risk management
Disease management program for the prevention of cardiovascular diseases

Locations

Country	Name	City	State
Netherlands	General Practices	Zwolle	Overijssel

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Hein Hogerzeil Stichting, Isala Klinieken, Zwolle, Medrie Health Care Group, Zwolle

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Dyakova M, Shantikumar S, Colquitt JL, Drew CM, Sime M, MacIver J, Wright N, Clarke A, Rees K. Systematic versus opportunistic risk assessment for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2016 Jan 29;(1):CD010411. doi: — View Citation

Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD001561. doi: 10.1002/14651858.CD001561.pub3. Review. — View Citation

Khunti K, Stone M, Paul S, Baines J, Gisborne L, Farooqi A, Luan X, Squire I. Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial. Heart. 2007 Nov;93(11): — View Citation

Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. Italian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	LDL-cholesterol	Blood sample	After 1 year of follow-up
Secondary	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
Secondary	Smoking status	Smoking yes or no	After 1 year of follow-up
Secondary	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
Secondary	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
Secondary	Physical activity	Squash questionnaire	After 1 year of follow-up
Secondary	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
Secondary	Awareness of received lifestyle advices	Aware/ not aware of received lifestyle advices, measured by questionairre	After 1 year of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Awareness of cardiovascular disease risk	Estimation by patient of his/her own cardiovascular disease risk by a questionairre	After 1 year of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Morbidity	Newly developed cardiovascular diseases	After 1 year of follow-up
Secondary	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
Secondary	Newly developed COPD	Newly developed COPD, based on coded diagnosis in electronic medical record in general practice	After 1 year of follow-up
Secondary	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
Secondary	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
Secondary	Mortality	Died due to cardiovascular disease or other cause	After 1 year of follow-up
Secondary	Primary treating practitioner in the context of cardiovascular risk management	General practitioner or medical specialist.	After 1 year of follow-up
Secondary	Health care consumption in the past year	Consultations in the contect ox cardiovascular risk management in general practice	After 1 year of follow-up
Secondary	Self-management in the past year	Patient Activity Measure (PAM)	After 1 year of follow-up
Secondary	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
Secondary	Patient satisfaction regarding the provided care in the past year	Patient Reported Experience Measure (PREM)	After 1 year of follow-up
Secondary	Quality of life	EQ-5D	After 1 year of follow-up
Secondary	Quality of life	SF-12	After 1 year of follow-up
Secondary	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
Secondary	Cost-efficiency	iPCQ	After 1 year of follow-up