The ZWOlle Transmural Integrated Care for CArdiovaScular Risk Management Study

NCT03428061 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 740

Last updated 2018-02-09

No results posted yet for this study

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

Interventions

OTHER

Integrated care for cardiovascular risk management

Disease management program for the prevention of cardiovascular diseases

Sponsors & Collaborators

  • Isala

    collaborator OTHER
  • Medrie Health Care Group, Zwolle

    collaborator UNKNOWN
  • Hein Hogerzeil Stichting

    collaborator UNKNOWN
  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Arno Hoes, Prof. MD PhD · Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht

  • Monika Hollander, MD PhD · Julius Center for Health Sciences and Primary Care/ University Medical Center Utrecht

  • Arnoud van 't Hof, Prof. MD PhD · Maastricht University Medical Center, department of cardiology

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428061 on ClinicalTrials.gov