Heart Failure Acute, Heart Failure，Congestive, Heart Failure; With Decompensation
Conditions
Keywords
Telemedicine, Telemonitoring, Hospital at Home, Home Hospitalization
Brief summary
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.
Interventions
DEVICETelemedicine/telemonitoring (TM) suite
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.
Sponsors
Santer Reply S.p.A. Milan, Italy
Caretek S.r.l. Turin, Italy
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily number of physician visits | From allocation through to HaH discharge, in mean 15 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily number of nurse visits | From allocation through to HaH discharge, in mean 15 days | 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 |
| Mean daily number of urgent physician visits | From allocation through to HaH discharge, in mean 15 days | 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 |
| Mean daily number of urgent nurse visits | From allocation through to HaH discharge, in mean 15 days | 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 |
| Overall mortality | From allocation through to HaH discharge, in mean 15 days | Death by any cause during Hospital at Home (HaH) stay |
| Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12) | At HaH discharge, in mean 15 days after allocation | 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 |
| Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12) | At patient's HaH discharge, in mean 15 days after allocation | 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 |
Countries
Italy
Contacts
Primary ContactRenata Marinello, MD, PhD
Outcome results
None listed