Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study
- Conditions
- Heart Failure AcuteHeart Failure，CongestiveHeart Failure; With Decompensation
- Interventions
- Device: Telemedicine/telemonitoring (TM) suite
- Registration Number
- NCT04403659
- Lead Sponsor
- A.O.U. Città della Salute e della Scienza
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Telemedicine/telemonitoring (TM) suite Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, TO, Italy