NCT07208331

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Oct 2030

First Submitted

Initial submission to the registry

September 25, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

September 25, 2025

Last Update Submit

October 2, 2025

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)HypertensionDyslipidemia

Keywords

TelemonitoringLipidseHealthScreeningTelemedicineRisk factor managementBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Number of patients on-target for LDL-c

    Proportion of patients achieving guideline-recommended LDL-c targets

    Baseline and 1 year

Secondary Outcomes (11)

  • Mean LDL-c

    Baseline and 1 year follow-up

  • Number of patients achieving blood pressure control

    Baseline and 1 year

  • Change in home-measured blood pressure values

    Baseline and 1 year

  • Number of medication changes

    1 year

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

    Baseline and 1 year

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients enrolled in the digital CVRM program will be invited to participate in this registry.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Centers of the Netherlands (CCN)

Amsterdam, North Holland, Netherlands

Location

MeSH Terms

Conditions

AtherosclerosisHypertensionDyslipidemias

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Youri Schut, MSc

CONTACT

+31205668051y.schut@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 6, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2030

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations

NL(1)