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

May 21, 2020 updated by: Dott.ssa RENATA MARINELLO, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

"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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TO
      • Torino, TO, Italy, 10126
        • S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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

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.
No Intervention: Control
Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily number of physician visits
Time Frame: 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
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
Time Frame: 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
From allocation through to HaH discharge, in mean 15 days
Mean daily number of urgent physician visits
Time Frame: 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
From allocation through to HaH discharge, in mean 15 days
Mean daily number of urgent nurse visits
Time Frame: 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
From allocation through to HaH discharge, in mean 15 days
Overall mortality
Time Frame: From allocation through to HaH discharge, in mean 15 days
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)
Time Frame: 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
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)
Time Frame: 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
At patient's HaH discharge, in mean 15 days after allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Collaborators

Caretek S.r.l. Turin, Italy
Santer Reply S.p.A. Milan, Italy

Investigators

  • Principal Investigator: Renata Marinello, MD, PhD, OAU Città della Salute e della Scienza di Torino, Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MONTEROSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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