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
- HF related hospitalization
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
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.
All cause death
时间窗: All cause death rate during the 15 month duration of the study.
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