The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

NCT03428061 | Unknown

• 1 other identifier: 57867
• Study Type: observational
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Hypertension

Keywords

Prevention; Disease Management; Integrated care; Primary Health Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (31)

• 10-years cardiovascular morbidity or mortality risk

  After 1 year of follow-up

• Smoking status

  After 1 year of follow-up

• Body mass index (BMI)

  After 1 year of follow-up

• Healthy diet

  After 1 year of follow-up

• Physical activity

  After 1 year of follow-up

Study Arms (2)

Intervention group

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

Control group

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.

Interventions

Integrated care for cardiovascular risk management OTHER

Disease management program for the prevention of cardiovascular diseases

Intervention group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Isala: collaborator
• Medrie Health Care Group, Zwolle: collaborator
• Hein Hogerzeil Stichting: collaborator

Study Sites (1)

General Practices

Zwolle, Overijssel, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 28714997 BACKGROUND

• 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.

  PMID: 26824223 RESULT

• 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.

  PMID: 17309907 RESULT

• 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.

  PMID: 21249647 RESULT

• 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.

  PMID: 31675925 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Hypertension

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases

Study Officials

• Arno Hoes, Prof. MD PhD

  Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht

  STUDY CHAIR

• Monika Hollander, MD PhD

  Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht

  PRINCIPAL INVESTIGATOR

• Arnoud van 't Hof, Prof. MD PhD

  Maastricht University Medical Center, department of cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 9, 2018
• Study Start: September 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)