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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04403659
Other study ID # MONTEROSA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date January 31, 2021

Study information

Verified date May 2020
Source Azienda Ospedaliera Città della Salute e della Scienza di Torino
Contact Renata Marinello, MD, PhD
Phone 0116334771
Email rmarinello@cittadellasalute.to.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino Torino TO

Sponsors (3)

Lead Sponsor Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino Caretek S.r.l. Turin, Italy, Santer Reply S.p.A. Milan, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-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. Erratum in: Eur Heart J. 2016 Dec 30;:. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean daily number of nurse visits 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
Secondary Mean daily number of urgent physician visits 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
Secondary Mean daily number of urgent nurse visits 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
Secondary Overall mortality Death by any cause during Hospital at Home (HaH) stay From allocation through to HaH discharge, in mean 15 days
Secondary Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12) 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
Secondary Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12) 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
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