Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory
NCT ID: NCT03764709
Last Updated: 2018-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2019-01-27
2021-03-31
Brief Summary
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Phase\*: 4, observational prospective
Number of subjects\*:
GROUP A and GROUP B: N=300 patients (150 per arm)
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Detailed Description
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Objectives\*
Some preliminary data on wireless monitoring in IMU have shown that the timely identification of clinical instability could led to a shorter length of stay. Monitoring on clinically unstable patients lets to prevent the deterioration of adverse events, thus allowing a rapid onset of intervention. There are some expected outcomes following the adoption of a wireless clinical monitoring system:
1. Shorter length of stay and earlier discharge
2. Lower transition rate to Intensive Care Unit (ICU)
3. Earlier transition of patients from higher to lower intensity of care
4. Shorter time needed by nurses for the detection of vital signs and clinical parameters, and possibility to dedicate to high-quality activities
Therefore the present study aims to provide data regarding the impact of a specific and oriented integrated remote system for the monitoring of vital status of critically ill patients in the improvement of outcomes and in a more efficient prevision of length of stay and costs, and to verify whether the regular use of a wireless remote monitoring system could improve the quality of the assistance and reduce major complications vs. a traditional monitoring of clinical status executed by the nursing staff, in two specific settings of critically ill patients referring to Internal Medicine with acute conditions:
GROUP A: Patients who undergo a transition to a subacute intensive care unit, in terms of reduction of re-exacerbation, re-access to emergency department or need of intervention by Internal Medicine unit specialists by the use of wireless monitoring vs. traditional monitoring.
GROUP B: Patients who are selected for an earlier discharge from Internal Medicine Unit, in terms of non-inferiority in the incidence of major clinical complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Vital signs wireless monitoring system GROUP A
GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.
The experimental arm will wear wireless monitoring for 5 days after transfer in subacute care unit
Vital signs wireless monitoring system
WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
Control arm GROUP A
GROUP A clinical hypothesis: reduction in the number of exacerbations in stable inpatients who transit towards subacute managed care unit.
The active comparator arm will be monitored by nursing staff.
Vital signs wireless monitoring system
WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
Vital signs wireless monitoring system GROUP B
GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home.
The experimental arm will wear wireless monitoring for 5 days after discharge at home
Vital signs wireless monitoring system
WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
Control Arm GROUP B
GROUP B clinical hypothesis: non-inferiority in the number of major clinical complications that, if treated at an earlier stage, can improve outcomes in stable patients who are selected for earlier discharge and are followed by a remote wireless monitoring at home.
The active comparator arm will perform usual checks by caregivers at home.
Vital signs wireless monitoring system
WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
Interventions
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Vital signs wireless monitoring system
WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
Eligibility Criteria
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Inclusion Criteria
2\. For GROUP A: eligibility to the transition towards subacute managed care unit (based on clinical evaluation).
3\. For GROUP B: eligibility to early discharge based on clinical evaluation and stable MEWS/NEWS scores.
Exclusion Criteria
* Lack of informed consent/unwillingness to participate
* MEWS/NEWS out of range
* Transition to rehabilitation, Hospice, RSA or other Acute unit
* Pacemaker carriers
ALL
No
Sponsors
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ASL Roma 6
OTHER
Azienda Socio Sanitaria Territoriale del Garda
OTHER_GOV
Responsible Party
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Filomena Pietrantonio
Internal Medicina unit Director
Locations
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ASL Roma6
Albano Laziale, Roma, Italy
Countries
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Central Contacts
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Facility Contacts
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Filomena Pietrantonio
Role: primary
References
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F. Pietrantonio, L. Piasini, F. Spandonaro. Internal Medicine and emergency admissions: from a national Hospital Discharge Records (SDO) study to a regional analysis. Italian Journal of Medicine Italian Journal of Medicine 2016; volume 10:157-167
Blais R, Sears NA, Doran D, Baker GR, Macdonald M, Mitchell L, Thales S. Assessing adverse events among home care clients in three Canadian provinces using chart review. BMJ Qual Saf. 2013 Dec;22(12):989-97. doi: 10.1136/bmjqs-2013-002039. Epub 2013 Jul 4.
Sears N, Baker GR, Barnsley J, Shortt S. The incidence of adverse events among home care patients. Int J Qual Health Care. 2013 Feb;25(1):16-28. doi: 10.1093/intqhc/mzs075. Epub 2013 Jan 2.
Pietrantonio F, Orlandini F, Moriconi L, La Regina M. Acute Complex Care Model: An organizational approach for the medical care of hospitalized acute complex patients. Eur J Intern Med. 2015 Dec;26(10):759-65. doi: 10.1016/j.ejim.2015.08.011. Epub 2015 Sep 11.
Masotti P, McColl MA, Green M. Adverse events experienced by homecare patients: a scoping review of the literature. Int J Qual Health Care. 2010 Apr;22(2):115-25. doi: 10.1093/intqhc/mzq003. Epub 2010 Feb 10.
Doran D, Hirdes JP, Blais R, Baker GR, Poss JW, Li X, Dill D, Gruneir A, Heckman G, Lacroix H, Mitchell L, O'Beirne M, Foebel A, White N, Qian G, Nahm SM, Yim O, Droppo L, McIsaac C. Adverse events associated with hospitalization or detected through the RAI-HC assessment among Canadian home care clients. Healthc Policy. 2013 Aug;9(1):76-88.
Vincent C, Amalberti R. Safer Healthcare: Strategies for the Real World [Internet]. Cham (CH): Springer; 2016. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK481869/
F. Pietrantonio. Analisi dei modelli esistenti: Acute Complex Care Model (ACCM). QUADERNI - Italian Journal of Medicine 2018; volume 6(3):18-29
Brown H, Terrence J, Vasquez P, Bates DW, Zimlichman E. Continuous monitoring in an inpatient medical-surgical unit: a controlled clinical trial. Am J Med. 2014 Mar;127(3):226-32. doi: 10.1016/j.amjmed.2013.12.004. Epub 2013 Dec 14.
Tartaglia R, Albolino S, Bellandi T, Bianchini E, Biggeri A, Fabbro G, Bevilacqua L, Dell'erba A, Privitera G, Sommella L. [Adverse events and preventable consequences: retrospective study in five large Italian hospitals]. Epidemiol Prev. 2012 May-Aug;36(3-4):151-61. Italian.
Charles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012
Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
Bellocco A. Risk management in ospedale. Risk News CINEAS (Consorzio Universitario per l'Ingegneria nelle Assicurazioni) 2002;23.
Sensium Science MF06-01, April 2015
Miglioramento della qualità della vita dei pazienti e riduzione del costo per il SSN attraverso l'uso di un sistema wireless di monitoraggio multi-parametrico dei parametri fisiologici. Case study sull'adozione del sistema di monitoraggio fisiologico WIN@Hospital presso l'Ospedale Campo di Marte, Lucca. Cangemi A, Turchetti B. Europe Health Summit Berlino (4-8 Maggio 2014)
Other Identifiers
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Green Light HT 2018
Identifier Type: -
Identifier Source: org_study_id
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