Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Number of patients on-target for LDL-c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •All patients enrolled in the program (high-risk and very high-risk patients)
排除标准
- •Not able to provide informed consent
- •No access to smartphone and/or tablet
- •Inability to use digital tools required for the program
结局指标
主要结局
Number of patients on-target for LDL-c
时间窗: Baseline and 1 year
Proportion of patients achieving guideline-recommended LDL-c targets
次要结局
- All-cause mortality(12 and 24 months)
- Visual Analog Scale (VAS) for medication adherence(Baseline and 1 year)
- Telehealth Usability Questionnaire (TUQ)(Baseline and 1 year)
- Hospitalization(12 and 24 months)
- Number of medication changes(1 year)
- 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)
- 5-item Medication Adherence Report Scale (MARS-5)(Baseline and 1 year)
- Quality of life (QoL)(Baseline and 1 year)
- MACE(12 and 24 months)
研究者
M.M. Winter
MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)