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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COMPLETED
796 participants
OBSERVATIONAL
2020-11-01
2022-01-16
Brief Summary
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The collaboration between hospital and territory with integrated communication systems and the monitoring of patients with appropriate technological tools that include telemedicine, are fundamental to ensure the continuity of care and the sustainability of the health system, also significantly reducing the risk of contagion for health professionals.
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Detailed Description
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Patients discharged from hospitals still present in many cases breathing difficulties, bed rest symptoms and other disabilities related to the acute event. In addition, some patients are seeing rekindling of symptoms such as fever, dry cough, difficulty respiratory and blood desaturation into oxygen. These problems underline the need for procedures that allow us to safely discharge patients to be able to better follow their convalescence but also to be able to intervene quickly in the event of symptoms returning.
The purpose of the home health surveillance intervention will be:
* Monitor the evolution of the state of health with standardized tools based on scientific evidence
* Provide counselling support to help recovery
* Have certain and early identification of signs and symptoms related to a possible resumption of the COVID19 pathology and or to comorbidities
* Compare outcome results with case-control design three months after hospital discharge
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Telecare group
When discharged, patients will be followed at home by a telecare nursing and specialist teleconsultation program for 3 months. The key element of the program will be a structured nurse-managed telephone support and, when necessary, video consultations, to follow patients, for the first month. During these contacts, the nurse will conduct a standardized interview enquiring about the general clinical condition of the patient. In the case of any symptom or problem, the patient will be able to call the service. At the end of the third month, patients will contact again to check their clinical condition and to close the program. Patients will be provided with a pulse oximeter to measure O2 saturation.
At the start and end of the program, patients were administered the SF-12 quality of life questionnaire.
Telecare Group
Home-based telehealth program: telenursing and specialist teleconsultation
Telemonitoring with a new pulse oximeter and specific App
E-health platform
Videoconference
Control group
The patients in the control group will be followed by their general practitioner and they will be contacted after three months to check their clinical condition.
Control group
Usual care
Interventions
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Telecare Group
Home-based telehealth program: telenursing and specialist teleconsultation
Telemonitoring with a new pulse oximeter and specific App
E-health platform
Videoconference
Control group
Usual care
Eligibility Criteria
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Inclusion Criteria
* Patients discharged at home
Exclusion Criteria
* Patients discharged at a nursing home
18 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Azienda Ospedaliera Bolognini di Seriate Bergamo
OTHER
Azienda Socio Sanitaria Territoriale di Bergamo
UNKNOWN
University of Bergamo
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Principal Investigators
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Simonetta Scalvini, MD
Role: STUDY_CHAIR
Istituti Clinici Scientifici Maugeri
Locations
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Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate
Seriate, Bergamo, Italy
Ics Maugeri
Lumezzane, Brescia, Italy
Ics Maugeri
Tradate, Varese, Italy
Istituto Auxologico Italiano
Milan, , Italy
Countries
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References
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Word Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available at https://covid19.who.int 2020. (last accessed March 2021).
Tebeje TH, Klein J. Applications of e-Health to Support Person-Centered Health Care at the Time of COVID-19 Pandemic. Telemed J E Health. 2021 Feb;27(2):150-158. doi: 10.1089/tmj.2020.0201. Epub 2020 Jul 31.
Doshi A, Platt Y, Dressen JR, Mathews BK, Siy JC. Keep Calm and Log On: Telemedicine for COVID-19 Pandemic Response. J Hosp Med. 2020 May;15(5):302-304. doi: 10.12788/jhm.3419. Epub 2020 Apr 1. No abstract available.
Tabacof L, Kellner C, Breyman E, Dewil S, Braren S, Nasr L, Tosto J, Cortes M, Putrino D. Remote Patient Monitoring for Home Management of Coronavirus Disease 2019 in New York: A Cross-Sectional Observational Study. Telemed J E Health. 2021 Jun;27(6):641-648. doi: 10.1089/tmj.2020.0339. Epub 2020 Oct 13.
Scalvini S, Bernocchi P, Zanelli E, Comini L, Vitacca M; Maugeri Centre for Telehealth and Telecare (MCTT). Maugeri Centre for Telehealth and Telecare: A real-life integrated experience in chronic patients. J Telemed Telecare. 2018 Aug;24(7):500-507. doi: 10.1177/1357633X17710827. Epub 2017 May 24.
Vitali A, Ghidotti A, Savoldelli A, Bonometti F, Rizzi C, Bernocchi P, Borghi G, Scalvini S. Definition of a Method for the Evaluation of Telemedicine Platforms in the Italian Context. Telemed J E Health. 2023 May;29(5):769-777. doi: 10.1089/tmj.2022.0326. Epub 2022 Oct 7.
Bernocchi P, Crotti G, Beato E, Bonometti F, Giudici V, Bertolaia P, Perger E, Remuzzi A, Bachetti T, La Rovere MT, Dalla Vecchia LA, Angeli F, Parati G, Borghi G, Vitacca M, Scalvini S. COVID-19 teleassistance and teleconsultation: a matched case-control study (MIRATO project, Lombardy, Italy). Front Cardiovasc Med. 2023 Aug 14;10:1062232. doi: 10.3389/fcvm.2023.1062232. eCollection 2023.
Bonometti F, Bernocchi P, Vitali A, Savoldelli A, Rizzi C, Scalvini S. Usability of a continuous oxygen saturation device for home telemonitoring. Digit Health. 2023 Aug 14;9:20552076231194547. doi: 10.1177/20552076231194547. eCollection 2023 Jan-Dec.
Other Identifiers
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ICS Maugeri CE2455
Identifier Type: -
Identifier Source: org_study_id
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