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

NCT ID: NCT07208331

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-06

Study Completion Date

2030-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerotic Cardiovascular Disease (ASCVD) Hypertension Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiology Centres of the Netherlands

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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M.M. Winter

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiology Centers of the Netherlands (CCN)

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Youri Schut, MSc

Role: CONTACT

+31205668051

Facility Contacts

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Youri Schut, MSC

Role: primary

+31205668051

Other Identifiers

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2025.0543

Identifier Type: -

Identifier Source: org_study_id

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