Clinical trial NCT04403659: Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study
Official title: Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure; With Decompensation
Heart Failure，Congestive
Heart Failure Acute
Keywords: Telemedicine
Telemonitoring
Hospital at Home
Home Hospitalization
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: Santer Reply S.p.A. Milan, Italy
name: Caretek S.r.l. Turin, Italy
First posted: 2020-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean daily number of physician visits
timeFrame: From allocation through to HaH discharge, in mean 15 days
Secondary outcomes:
measure: Mean daily number of nurse visits
timeFrame: From allocation through to HaH discharge, in mean 15 days
measure: Mean daily number of urgent physician visits
timeFrame: From allocation through to HaH discharge, in mean 15 days
measure: Mean daily number of urgent nurse visits
timeFrame: From allocation through to HaH discharge, in mean 15 days
measure: Overall mortality
timeFrame: From allocation through to HaH discharge, in mean 15 days
measure: Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)
timeFrame: At HaH discharge, in mean 15 days after allocation
measure: Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)
timeFrame: At patient's HaH discharge, in mean 15 days after allocation
Other outcomes:
Locations:
city: Torino
country: Italy
facility: S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino
state: TO
Study officials:
affiliation: OAU Città della Salute e della Scienza di Torino, Turin, Italy
name: Renata Marinello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1097/00005650-199603000-00003.