Patient MonitoringGreenLightHTNCT03764709
Continuous Wireless Monitoring in Internal Medicine Unit: the Green Line From Hospital to Territory
A study testing Vital signs wireless monitoring system in people with Patient Monitoring, run by Azienda Socio Sanitaria Territoriale del Garda at 1 site in Italy.
Trial summary
Study Information Indication* This is a prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Monitoring
- What is being tested?
- Vital signs wireless monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. All patients admitted to the Internal Medicine Unit regardless of the reason for admission.
- 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.
Who cannot join
- - Inability to discernment
- Lack of informed consent/unwillingness to participate
- MEWS/NEWS out of range
- Transition to rehabilitation, Hospice, RSA or other Acute unit
- Pacemaker carriers
Trial locations and contacts
1 site in 1 country.
Italy1 site
ASL Roma6
Albano Laziale, Roma, 00040
Filomena Pietrantonio, 3291710748
About this study
Official title: The Technological Challenge of Continuous Wireless Monitoring in Internal Medicine Unit to Improve Management of Complex Patients: the Green Line From Hospital to Territory (Green Line H-T Study)
Study Information Indication* This is a prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).
Phase*: 4, observational prospective
Number of subjects*:
GROUP A and GROUP B: N=300 patients (150 per arm)
Read the detailed description
Background and Rationale* In IMU there is an increasing concentration of patients with serious illness, under acute exacerbation of previous diseases, elderly patients with co-morbidities and/or fragility, needing high intensity care. Those patients need an overall evaluation of the rank of severity, complexity and dependence of their pathology, together with an evaluation of their risk of clinical deterioration, to implement a stratification of optimal treatments, intensity of care, length of stay. This could allow to optimize the approach to the complexity of the patients while helping containing costs, not only on the patients who are evaluated during their stay in IMUs, but also in those patients who undergo protected hospital discharge or transition to subacute intensive care unit.
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:
- Shorter length of stay and earlier discharge
- Lower transition rate to Intensive Care Unit (ICU)
- Earlier transition of patients from higher to lower intensity of care
- 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
- Patient Monitoring
- Being tested
- Vital signs wireless monitoring system
- Keywords
- Wireless monitoring, hospital-territory integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital signs wireless monitoring systemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Vital signs wireless monitoring system GROUP A | Experimental | 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 Receives: Device: Vital signs wireless monitoring system |
| Control arm GROUP A | Active comparator | 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. Receives: Device: Vital signs wireless monitoring system |
| Vital signs wireless monitoring system GROUP B | Experimental | 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 Receives: Device: Vital signs wireless monitoring system |
| Control Arm GROUP B | Active comparator | 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. Receives: Device: Vital signs wireless monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications' reduction
Difference in the incidence of major complications 30 days after the transfer from the acute to the subacute areas and from the hospital to home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring.
Measured: 24 months
Secondary outcomes (3)
% of early discharge
Percentage of patients admitted to acute medicine who reach the 7-day transfer criteria in the ward for subacutes and percentage of patients admitted to acute medicine who reach the criteria for discharge at home within 7 days
Measured: 24 months
% of late major complications
- Difference in the incidence of major complications at the conclusion of the standard telemonitoring / clinical monitoring phase 30 after the transfer from the acute to the subacute UOC and from the hospital to the home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring .
Measured: 24 months
Complications' risk factors
Patients'characteristics who predispose to major complications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start27 Jan 2019 (estimated)
- Primary completion27 Jan 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale del Garda
- Sponsor type
- Other government
- Collaborators
- ASL Roma 6
- Responsible party
- Principal investigator, Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764709
- Sponsor's protocol ID
- Green Light HT 2018
- Acronym
- GreenLightHT
- Status last verified
- Dec 2018
- First submitted
- 28 Aug 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23828878Sears 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.
PubMed 23283731Pietrantonio 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.
PubMed 26365373Masotti 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.
PubMed 20147333Doran 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.
PubMed 23968676Vincent 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/
PubMed 29465922F. 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.
PubMed 24342543Tartaglia 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.
PubMed 22828228Charles 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/
PubMed 25077248Bellocco 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)
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Technological Challenge of Continuous Wireless Monitoring in Internal Medicine Unit to Improve Management of Complex Patients: the Green Line From Hospital to Territory (Green Line H-T Study)
- ClinicalTrials.gov ID
- NCT03764709
- Acronym / sponsor ID
- GreenLightHT / Green Light HT 2018
- Conditions
- Patient Monitoring
- Keywords
- Wireless monitoring, hospital-territory integration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale del GardaOther government
- Collaborators
- ASL Roma 6
- Study start
- 27 Jan 2019 (estimated)
- Primary completion
- 27 Jan 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Information Indication* This is a prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).
Phase*: 4, observational prospective
Number of subjects*:
GROUP A and GROUP B: N=300 patients (150 per arm)
Detailed description
Background and Rationale* In IMU there is an increasing concentration of patients with serious illness, under acute exacerbation of previous diseases, elderly patients with co-morbidities and/or fragility, needing high intensity care. Those patients need an overall evaluation of the rank of severity, complexity and dependence of their pathology, together with an evaluation of their risk of clinical deterioration, to implement a stratification of optimal treatments, intensity of care, length of stay. This could allow to optimize the approach to the complexity of the patients while helping containing costs, not only on the patients who are evaluated during their stay in IMUs, but also in those patients who undergo protected hospital discharge or transition to subacute intensive care unit.
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:
- Shorter length of stay and earlier discharge
- Lower transition rate to Intensive Care Unit (ICU)
- Earlier transition of patients from higher to lower intensity of care
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, randomized, controlled, open-label, monocentric study for the evaluation of two different settings of critically ill patients recovered in Internal Medicine unit (IMU) and subsequently sent to subacute managed care unit or to earlier discharge, in order to evaluate the effectiveness of a wireless monitoring of clinical conditions vs. a traditional clinical monitoring on outcomes (critical adverse events, clinical exacerbations).
| Arm | Type | Receives |
|---|---|---|
| Vital signs wireless monitoring system GROUP A | Experimental | Device: Vital signs wireless monitoring systemGROUP 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 |
| Control arm GROUP A | Active comparator | Device: Vital signs wireless monitoring systemGROUP 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 GROUP B | Experimental | Device: Vital signs wireless monitoring systemGROUP 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 |
| Control Arm GROUP B | Active comparator | Device: Vital signs wireless monitoring systemGROUP 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1. All patients admitted to the Internal Medicine Unit regardless of the reason for admission.
- 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.
Key exclusion criteria (5 listed)
- - Inability to discernment
- Lack of informed consent/unwillingness to participate
- MEWS/NEWS out of range
- Transition to rehabilitation, Hospice, RSA or other Acute unit
- Pacemaker carriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vital signs wireless monitoring systemWIN@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). | Device | Control Arm GROUP B, Control arm GROUP A, Vital signs wireless monitoring system GROUP A, Vital signs wireless monitoring system GROUP B |
Primary outcome
Major complications' reduction
Time frame: 24 months
Difference in the incidence of major complications 30 days after the transfer from the acute to the subacute areas and from the hospital to home among the patients subjected to continuous telemonitoring and those subjected to standard monitoring.
3 secondary outcomes
% of early discharge
Time frame: 24 months
% of late major complications
Time frame: 24 months
Complications' risk factors
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- BackgroundF. 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
- Background: PubMed 23828878Blais 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.
- Background: PubMed 23283731Sears 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.
- Background: PubMed 26365373Pietrantonio 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.
- Background: PubMed 20147333Masotti 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.
- Background: PubMed 23968676Doran 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.
- Background: PubMed 29465922Vincent 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/
- BackgroundF. Pietrantonio. Analisi dei modelli esistenti: Acute Complex Care Model (ACCM). QUADERNI - Italian Journal of Medicine 2018; volume 6(3):18-29
- Background: PubMed 24342543Brown 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.
- Background: PubMed 22828228Tartaglia 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.
- BackgroundCharles V. Sicurezza del paziente. Edizione italiana a cura di Tartaglia R, Albolino S, Bellandi T. Milano, Springer-Verlag Italia, 2012
- Background: PubMed 25077248Institute 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/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital signs wireless monitoring system in people with Patient Monitoring, run by Azienda Socio Sanitaria Territoriale del Garda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filomena Pietrantonio, MD (3291710748, filomena.pietrantonio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complications' reduction (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764709, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.