跳至主要内容
临床试验/NCT05017077
NCT05017077Unknown不适用

Home Telemonitoring in Pediatric Heart Failure

Bambino Gesù Hospital and Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Primary outcome

研究概览

简要总结

Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology. In pediatric population, it is particularly challenging to manage because of the heterogeneity in age, primary cardiac disease, and the broad range of clinical signs and symptoms. Frequent hospitalizations are current problem. Hospitalization within the first year since the first episode, lack of adherence to medical therapy and diet difficulties are the main issues in this population of patients, and they rebounds on prognosis and public health costs. Actions aimed to prevent and manage these matters will improve outcome in patients with chronic heart failure. Telemedicine proved its usefulness in adult population, but, nowadays, no studies have been conducted in children. From the beginning of 21th century, remote monitoring attempts have been adopted, initially by phone calls. Currently, the e-care monitoring fits in the context of telemedicine 2.0 based on new communication models. The aim of this study is to affirm the feasibility and efficacy of a new model of tele monitoring in pediatric population. High-risk patients need a strict clinical control normally difficult to adopt. A telematics system capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients. All of these data permits to physician to early detect critical signals of a deteriorated status, modify adherence to care and implement therapeutic strategies in order to prevent frequent hospitalizations. Our project provides a system of continuous tele-monitoring of vital parameters through a patch applied on the chest of the baby. Data are sent to a service center, "virtual clinic" and daily analyzed in multiparametric system by a specialized nurse. On the basis of pre-established alarms, the virtual clinic will notify to physician. Feasibility and tolerability of this new monitoring system will be evaluated after a 3 months period on a cohort of 20 patients affected by chronic, high-risk, heart failure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • NYHA/Ross class III or IV
  • Severe impairment of ventricular function (EF < 40%) both for left or univentricular
  • Prior hospitalization for acute heart failure within 1 year
  • At least 2 prior hospitalization for acute heart failure
  • Patients on waiting list for orthotopic heart transplantation (UNOS 1B,2)
  • Informed consent obtained

排除标准

  • PMK or ICD
  • hospitalized patients
  • neurological or psychiatric impairment
  • urgent waiting list for heart transplantation (UNOS 1A)

结局指标

主要结局

Primary outcome

时间窗: three months

number of day (percentage) of adherence to telemonitoring, at least 18 hours per day when the patient kept the patch applied at 3 months.

次要结局

  • Comparison to levels of Albumin (g/dL)(3 months)
  • Number of life treating arrhythmias(3 months)
  • Mortality(3 months)
  • Comparison to levels of Potassium (mEq/L)(3 months)
  • Comparison to levels of Serum Creatinine (mg/dL)(3 months)
  • Satisfaction questionnaire(3 months)
  • Number of hours of patch kept applied(at 3 months)
  • Interquartile Range - median of hours of patch kept applied(at 3 months)
  • Number of unplanned hospitalization(3 months)
  • Number of unplanned hospital access (day hospital / ambulatory)(3 months)
  • Comparison to levels of Hemoglobin (g/dL)(3 months)
  • Comparison to levels of Sodium (mEq/L)(3 months)

研究者

发起方
Bambino Gesù Hospital and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachele Adorisio

Principal Investigator

Bambino Gesù Hospital and Research Institute

研究点 (2)

Loading locations...

相似试验

Home Monitoring in Pediatric Heart Failure | 临床试验