Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,320
- 试验地点
- 5
- 主要终点
- All cause death
研究概览
简要总结
This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All heart failure diagnoses
- •>18 years
排除标准
- •Not understanding the Dutch Language.
- •Allergies that make uptitration impossible.
- •Admission to hospice or palliative care.
- •Severe psychological disorders.
研究组 & 干预措施
Intervention
All cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care.
干预措施: Nudging (Combination Product)
结局指标
主要结局
All cause death
时间窗: All cause death rate during the 15 month duration of the study.
HF related hospitalization
时间窗: From enrollment to the end of the design (15 months).
The frequency of HF related hospitalization and duration of the hospitalization.
次要结局
未报告次要终点
研究者
Mark Schuuring
Assistent Professor M.J. Schuuring (M.D., Ph. D., FESC, FEACVI, FHFA)
Medisch Spectrum Twente