Home Monitoring in Pediatric Heart Failure

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Home Telemonitoring in Pediatric Heart Failure

Conditions
-----------------
Pediatric Heart Failure

Intervention / Treatment
-----------------
* Device: DynaVision System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: PMK or ICD hospitalized patients neurological or psychiatric impairment urgent waiting list for heart transplantation (UNOS 1A)

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>To evaluate the feasibility and efficacy of a new model of tele monitoring in pediatric population in advanced heart failure, we will enroll 20 patients in advanced NYHA/Ross class in waiting list for Heart Transplant. An home telemonitoring 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 | Device: DynaVision System<br>* Telemonitoring for pediatric heart failure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | number of day (percentage) of adherence to telemonitoring, at least 18 hours per day when the patient kept the patch applied at 3 months. | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours of patch kept applied | Tolerability | at 1 week | 
| Number of hours of patch kept applied | Tolerability | at 3 months | 
| Interquartile Range - median of hours of patch kept applied | Tolerability | at 1 week | 
| Interquartile Range - median of hours of patch kept applied | Tolerability | at 3 months | 
| Number of unplanned hospitalization | Reliability | 3 months | 
| Number of life treating arrhythmias | Reliability | 3 months | 
| Mortality | Reliability | 3 months | 
| Number of unplanned hospital access (day hospital / ambulatory) | Reliability | 3 months | 
| Comparison to levels of Hemoglobin (g/dL) | Reliability | 3 months | 
| Comparison to levels of Albumin (g/dL) | Reliability | 3 months | 
| Comparison to levels of Sodium (mEq/L) | Reliability | 3 months | 
| Comparison to levels of Potassium (mEq/L) | Reliability | 3 months | 
| Comparison to levels of Serum Creatinine (mg/dL) | Reliability | 3 months | 
| Satisfaction questionnaire | Satisfaction | 1 week | 
| Satisfaction questionnaire | Satisfaction | 3 months |