Heart Failure,Congestive Clinical Trial
— MONTEROSAOfficial title:
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.
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) |
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 |
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 |
Italy,
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
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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