Patient Monitoring Clinical Trial
— GreenLightHTOfficial 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)
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | March 31, 2021 |
Est. primary completion date | January 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | ASL Roma6 | Albano Laziale | Roma |
Lead Sponsor | Collaborator |
---|---|
Azienda Socio Sanitaria Territoriale del Garda | Internal Medicine Unit Albano ASL Roma 6 |
Italy,
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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. Review. — View Citation
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)
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 months | |
Secondary | % 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 | 24 months | |
Secondary | % of late major complications | 3. 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 . | 24 months | |
Secondary | Complications' risk factors | Patients'characteristics who predispose to major complications | 24 months |
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