Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07208331

Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management

The goal of this observational study is to evaluate the implementation of a structured, digital, nurse-led, remote monitoring care pathway for cardiovascular risk management (CVRM). Participants will receive this care as part of routine clinical practice. In addition to standard follow-up, participants will complete questionnaires on quality of life, medication adherence, system usability, and patient satisfaction.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemia Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Centers of the Netherlands (CCN)

Amsterdam, North Holland, Netherlands

Location contact

Youri Schut, MSC

CONTACT

[email protected]

+31205668051

About this study

CVRM is essential for patients at increased risk of cardiovascular disease (CVD) as well as for those with established atherosclerotic cardiovascular disease (ASCVD). Monitoring blood pressure and lipid profiles is crucial to achieving guideline-recommended targets. However, many patients fail to reach these targets despite the availability of effective therapies, resulting in an increased risk of recurrent events. Meanwhile, the burden of CVD continues to rise, creating significant pressure on healthcare systems.

A digital care pathway may improve therapy adherence and outcomes by enabling personalized, data-driven care. This study evaluates the effectiveness of a nurse-led, telemonitoring pathway for CVRM in routine practice, where patients measure their blood pressure and LDL-c levels at home. The study aims to improve risk stratification, support earlier intervention, and optimize lipid and blood pressure control, ultimately leading to better patient outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • All patients enrolled in the program (high-risk and very high-risk patients)

Exclusion criteria

  • Not able to provide informed consent
  • No access to smartphone and/or tablet
  • Inability to use digital tools required for the program

Treatment and study plan

Primary outcomes

  1. Number of patients on-target for LDL-c

    Time frame: Baseline and 1 year

    Proportion of patients achieving guideline-recommended LDL-c targets

Secondary outcomes

  1. Mean LDL-c

    Time frame: Baseline and 1 year follow-up

    The mean of LDL-c values in mmol/L, measured at-home

  2. Number of patients achieving blood pressure control

    Time frame: Baseline and 1 year

    Proportion of patients achieving guideline-recommended blood pressure targets

  3. Change in home-measured blood pressure values

    Time frame: Baseline and 1 year

    Change in blood pressure values measured at home with telemonitoring in mmHg

  4. Number of medication changes

    Time frame: 1 year

    Changes in lipid-lowering and antihypertensive medications, defined as change in dose and change in medication type

  5. 5-item Medication Adherence Report Scale (MARS-5)

    Time frame: Baseline and 1 year

    5 questions about medication adherence, with higher scores indicating better adherence

  6. Visual Analog Scale (VAS) for medication adherence

    Time frame: Baseline and 1 year

    The scale ranges from 0% to 100%, with higher scores indicating better medication adherence

  7. Quality of life (QoL)

    Time frame: Baseline and 1 year

    Using the EuroQoL-5D questionnaire

  8. Telehealth Usability Questionnaire (TUQ)

    Time frame: Baseline and 1 year

    18 questions on patient satisfaction and usability, with higher scores indicating better satisfaction

  9. Hospitalization

    Time frame: 12 and 24 months

    Unplanned cardiovascular (re)hospitalization

  10. MACE

    Time frame: 12 and 24 months

    Cardiovascular death, myocardial infarction, any documented stroke (ischemic or hemorrhagic), ischemia-driven revascularization

  11. All-cause mortality

    Time frame: 12 and 24 months

    Total number of deaths from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Youri Schut, MSc

CONTACT

[email protected]

+31205668051

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Cardiology Centres of the Netherlands

Registry information

Acronym: TELE-CVRM

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.