NCT04403659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 21, 2020

Last Update Submit

May 21, 2020

Conditions

Heart Failure; With DecompensationHeart Failure，CongestiveHeart Failure Acute

Keywords

TelemedicineTelemonitoringHospital at HomeHome Hospitalization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mean daily number of nurse visits

    From allocation through to HaH discharge, in mean 15 days

  • Mean daily number of urgent physician visits

    From allocation through to HaH discharge, in mean 15 days

  • Mean daily number of urgent nurse visits

    From allocation through to HaH discharge, in mean 15 days

  • Overall mortality

    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)

    At HaH discharge, in mean 15 days after allocation

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Telemedicine/telemonitoring (TM) suiteDEVICE

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Torino, TO, 10126, Italy

Location

Related Publications (3)

  • Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.

    PMID: 19786675BACKGROUND

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PMID: 27206819BACKGROUND

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Renata Marinello, MD, PhD

    OAU Città della Salute e della Scienza di Torino, Turin, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata Marinello, MD, PhD

CONTACT

0116334771rmarinello@cittadellasalute.to.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

June 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)