NCT07689760Enrolling By Invitation不适用
Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Heart failure (HF) event
研究概览
简要总结
The goal of this observational study is to develop and validate an XAI based model that predicts HF events and identifies modifiable con-tributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care in patients with heart failure. The main objectives of the study are:
- To develop and validate an XAI based model that predicts HF events and identifies modifiable contributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care. In the Netherlands usual care includes remote monitoring of heartrate, blood pressure, weight and symptoms.
- To include insights of the smartwatch into activity patterns, impact on quality of life (KCCQ-12), and patient satisfaction with net promoter score (NPS).
Participants will wear a smartwatch for six months and perform an I-lead ecg with the smartwatch weekly.
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
- •Adult HF patients
- •NYHA class II, or NYHA III
- •Rehospitalization for HF
- •Usual care with active participation in the telemonitoring program "Zorg Bij Jou" (ZBJ)
- •Possession of an iPhone 11 or newer and compatible with the study apps
排除标准
- •Lack of digital literacy or inability to use the device
- •Not capable to sign consent
- •Referral to hospice
研究组 & 干预措施
Heart failure patients
结局指标
主要结局
Heart failure (HF) event
时间窗: From enrollment to the end of follow-up at 6 months
HF event is defined as: * Increase in diuretic treatment * Increase in NYHA class * Hospitalization caused by HF * Death caused by HF
次要结局
- Activity patterns(From enrollment to the end of follow-up at 6 months)
- Quality of life (QoL)(Measured at baseline and at the end of follow-up at 6 months)
- Net promotor score (NPS)(At the end of follow-up at 6 months)
- Quality of life (QoL)(Measured at baseline and at the end of follow-up at 6 months. The Kansas City Cardiomyopathy Questionnaire is scored on a scale of 0 to 100; higher scores indicate better health.)
- Net promotor score(At the end of follow-up at 6 months)
研究者
研究点 (1)
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