Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atherosclerotic Cardiovascular Disease (ASCVD), Hypertension, Dyslipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Number of patients on-target for LDL-c [Time frame: Baseline and 1 year]
Secondary outcome measures (11)
- Mean LDL-c [Time frame: Baseline and 1 year follow-up]
- Number of patients achieving blood pressure control [Time frame: Baseline and 1 year]
- Change in home-measured blood pressure values [Time frame: Baseline and 1 year]
- Number of medication changes [Time frame: 1 year]
- 5-item Medication Adherence Report Scale (MARS-5) [Time frame: Baseline and 1 year]
- Visual Analog Scale (VAS) for medication adherence [Time frame: Baseline and 1 year]
- Quality of life (QoL) [Time frame: Baseline and 1 year]
- Telehealth Usability Questionnaire (TUQ) [Time frame: Baseline and 1 year]
- Hospitalization [Time frame: 12 and 24 months]
- MACE [Time frame: 12 and 24 months]
- All-cause mortality [Time frame: 12 and 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Cardiology Centers of the Netherlands (CCN) — Amsterdam
Identifiers
NCT: NCT07208331 · 2025.0543