Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study

Study Overview
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Brief Summary
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La Casa nel Parco (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a Hospital at Home service for acute decompensated heart failure. The main objective of the study will be to evaluate the impact of TM on number of daily physician's visits. Secondary objectives will be to evaluate the impact of TM on number of daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality of life.

Official Title
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Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota

Conditions
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Heart Failure; With Decompensation, Heart Failure，Congestive, Heart Failure Acute

Intervention / Treatment
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* Device: Telemedicine/telemonitoring (TM) suite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure Written informed consent signed by both the patient and the main caregiver Exclusion Criteria: Main caregiver with low IT skills (e.g. unable to use a smartphone); Patient in whom body weight or accurate daily urine output cannot be measured Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months Patient with decompensated liver cirrhosis (Child-Pugh score B o C)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care | Device: Telemedicine/telemonitoring (TM) suite<br>* The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily. The TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured.<br>|
| No Intervention: Control<br>Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily number of physician visits | Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient | From allocation through to HaH discharge, in mean 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily number of nurse visits | Mean daily number of nurse visits during Hospital at Home (HaH) stay, defined as total number of nurse visits during HaH stay, divided by days of HaH stay, for every single patient | From allocation through to HaH discharge, in mean 15 days | 
| Mean daily number of urgent physician visits | Mean daily number of urgent physician visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) physician visits during HaH stay, divided by days of HaH stay, for every single patient | From allocation through to HaH discharge, in mean 15 days | 
| Mean daily number of urgent nurse visits | Mean daily number of urgent nurse visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) nurse visits during HaH stay, divided by days of HaH stay, for every single patient | From allocation through to HaH discharge, in mean 15 days | 
| Overall mortality | Death by any cause during Hospital at Home (HaH) stay | From allocation through to HaH discharge, in mean 15 days | 
| Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12) | Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge | At HaH discharge, in mean 15 days after allocation | 
| Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12) | Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge | At patient's HaH discharge, in mean 15 days after allocation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Telemonitoring, Hospital at Home, Home Hospitalization