Atherosclerotic Cardiovascular Disease (ASCVD), Dyslipidemia, Hypertension
Conditions
Keywords
Telemonitoring, Lipids, eHealth, Screening, Telemedicine, Risk factor management, Blood pressure
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.
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.
Interventions
None listed
Sponsors
Cardiology Centres of the Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients on-target for LDL-c | Baseline and 1 year | Proportion of patients achieving guideline-recommended LDL-c targets |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 12 and 24 months | Unplanned cardiovascular (re)hospitalization |
| Change in home-measured blood pressure values | Baseline and 1 year | Change in blood pressure values measured at home with telemonitoring in mmHg |
| Number of medication changes | 1 year | Changes in lipid-lowering and antihypertensive medications, defined as change in dose and change in medication type |
| 5-item Medication Adherence Report Scale (MARS-5) | Baseline and 1 year | 5 questions about medication adherence, with higher scores indicating better adherence |
| Visual Analog Scale (VAS) for medication adherence | Baseline and 1 year | The scale ranges from 0% to 100%, with higher scores indicating better medication adherence |
| Telehealth Usability Questionnaire (TUQ) | Baseline and 1 year | 18 questions on patient satisfaction and usability, with higher scores indicating better satisfaction |
| Mean LDL-c | Baseline and 1 year follow-up | The mean of LDL-c values in mmol/L, measured at-home |
| Number of patients achieving blood pressure control | Baseline and 1 year | Proportion of patients achieving guideline-recommended blood pressure targets |
| MACE | 12 and 24 months | Cardiovascular death, myocardial infarction, any documented stroke (ischemic or hemorrhagic), ischemia-driven revascularization |
| All-cause mortality | 12 and 24 months | Total number of deaths from any cause |
| Quality of life (QoL) | Baseline and 1 year | Using the EuroQoL-5D questionnaire |
Countries
Netherlands
Contacts
Primary ContactYouri Schut, MSc
Outcome results
None listed