Clinical trial NCT03428061: The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study
Official title: The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Keywords: Prevention
Disease Management
Integrated care
Primary Health Care
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Isala
name: Medrie Health Care Group, Zwolle
name: Hein Hogerzeil Stichting
First posted: 2018-02-09
Enrollment: 740
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ZWOT-CASE study population will consist of a subgroup of 370 patients from the integrated CVRM care group (intervention) and 370 patients in the usual care (control) group. Both groups consist of respectively i) 185 patients with known CVD and ii) 185 patients with a high (\>10%) ten year risk of CVD morbidity and mortality based on the Dutch Guideline for CVRM.

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.


Eligibility 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: After 1 year of follow-up
measure: LDL-cholesterol
timeFrame: After 1 year of follow-up
Secondary outcomes:
measure: 10-years cardiovascular morbidity or mortality risk
timeFrame: After 1 year of follow-up
measure: Smoking status
timeFrame: After 1 year of follow-up
measure: Body mass index (BMI)
timeFrame: After 1 year of follow-up
measure: Healthy diet
timeFrame: After 1 year of follow-up
measure: Physical activity
timeFrame: After 1 year of follow-up
measure: Motivation to quit smoking
timeFrame: After 1 year of follow-up
measure: Awareness of received lifestyle advices
timeFrame: After 1 year of follow-up
measure: Awareness of food habits
timeFrame: After 1 year of follow-up
measure: Awareness of physical activity
timeFrame: After 1 year of follow-up
measure: Awareness of weight
timeFrame: After 1 year of follow-up
measure: Awareness of hyperlipidaemia
timeFrame: After 1 year of follow-up
measure: Awareness of cardiovascular disease risk
timeFrame: After 1 year of follow-up
measure: Awareness of hypertension
timeFrame: After 1 year of follow-up
measure: Use of adequate antihypertensives
timeFrame: After 1 year of follow-up
measure: Use of adequate lipid lowering drugs
timeFrame: After 1 year of follow-up
measure: Use of adequate anticoagulants
timeFrame: After 1 year of follow-up
measure: Morbidity
timeFrame: After 1 year of follow-up
measure: Newly developed diabetes mellitus
timeFrame: After 1 year of follow-up
measure: Newly developed COPD
timeFrame: After 1 year of follow-up
measure: Newly developed heart failure
timeFrame: After 1 year of follow-up
measure: Newly developed atrial fibrillation
timeFrame: After 1 year of follow-up
measure: Mortality
timeFrame: After 1 year of follow-up
measure: Primary treating practitioner in the context of cardiovascular risk management
timeFrame: After 1 year of follow-up
measure: Health care consumption in the past year
timeFrame: After 1 year of follow-up
measure: Self-management in the past year
timeFrame: After 1 year of follow-up
measure: Self-measurements of blood pressure in the past year
timeFrame: After 1 year of follow-up
measure: Patient satisfaction regarding the provided care in the past year
timeFrame: After 1 year of follow-up
measure: Quality of life
timeFrame: After 1 year of follow-up
measure: Quality of life
timeFrame: After 1 year of follow-up
measure: Anxiety and depression
timeFrame: After 1 year of follow-up
measure: Cost-efficiency
timeFrame: After 1 year of follow-up
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: General Practices
state: Overijssel
Study officials:
affiliation: Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht
name: Arno Hoes, Prof. MD PhD
role: STUDY_CHAIR
affiliation: Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht
name: Monika Hollander, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center, department of cardiology
name: Arnoud van 't Hof, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen 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. No abstract available. Italian.
citation: 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;2016(1):CD010411. doi: 10.1002/14651858.CD010411.pub2.
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):1398-405. doi: 10.1136/hrt.2006.106955. Epub 2007 Feb 19.
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;2011(1):CD001561. doi: 10.1002/14651858.CD001561.pub3.
citation: Marchal S, Hollander M, Schoenmakers M, Schouwink M, Timmer JR, Bilo HJG, Schwantje O, van 't Hof AWJ, Hoes AW. Design of the ZWOT-CASE study: an observational study on the effectiveness of an integrated programme for cardiovascular risk management compared to usual care in general practice. BMC Fam Pract. 2019 Nov 1;20(1):149. doi: 10.1186/s12875-019-1039-z.