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

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status: Unknown

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

Treatments: Device: Telemedicine/telemonitoring (TM) suite

Study type: Interventional

Funder types: Other

Identifiers

NCT04403659

MONTEROSA

Details and patient eligibility

About

"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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care

Treatment:

Device: Telemedicine/telemonitoring (TM) suite

Control

No Intervention group

Description:

Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines