Support for COVID19 Patients at Home

NCT04898179 | Completed

• 1 other identifier: ICS Maugeri CE2455
• Study Type: observational
• Target: 796
• Locations: 1 country
• Sites: 4

Brief Summary

The rapid spread and increase of acute respiratory infection cases caused by the novel SARS-CoV-2 coronavirus represent a major challenge for healthcare systems around the world. The shortage of facilities and medical personnel is a major problem in the face of a serious epidemic. The Lombardy Region, and in particular the territories of Milan, Bergamo and Brescia, was the most affected due to the rapid increase in cases and limited medical resources during the initial phase of the epidemic. 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.

Conditions

COVID19 Patients

Outcome Measures

Primary Outcomes (3)

• Number of Re-hospitalisation at three months

  Number of Re-hospitalisation registered at three months period in two groups

  3 months

• ER access at three months

  Number of ER accesses registered at three months period in two groups

  3 months

• Death at three months

  Number of death at three months in two groups

  3 months

Study Arms (2)

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.

Other: Telecare Group

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.

Other: Control group

Interventions

Telecare Group OTHER

Home-based telehealth program: telenursing and specialist teleconsultation Telemonitoring with a new pulse oximeter and specific App E-health platform Videoconference

Telecare group

Control group OTHER

Usual care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized for COVID19

You may qualify if:

• Hospitalisation for COVID19
• Patients discharged at home

You may not qualify if:

• Patient refusal
• Patients discharged at a nursing home

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Istituto Auxologico Italiano: collaborator
• Azienda Ospedaliera Bolognini di Seriate Bergamo: collaborator
• Azienda Socio Sanitaria Territoriale di Bergamo: collaborator
• University of Bergamo: collaborator

Study Sites (4)

Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate

Seriate, Bergamo, Italy

Location

Ics Maugeri

Lumezzane, Brescia, 25065, Italy

Location

Ics Maugeri

Tradate, Varese, Italy

Location

Istituto Auxologico Italiano

Milan, Italy

Location

Related Publications (8)

• Word Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available at https://covid19.who.int 2020. (last accessed March 2021).

  BACKGROUND

• 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.

  PMID: 32746750 BACKGROUND

• 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.

  PMID: 32379036 BACKGROUND

• 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.

  PMID: 33232204 BACKGROUND

• 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.

  PMID: 28537509 BACKGROUND

• 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.

  PMID: 36206021 BACKGROUND

• 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.

  PMID: 37645519 RESULT

• 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.

  PMID: 37588158 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Simonetta Scalvini, MD

  Istituti Clinici Scientifici Maugeri

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 24, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 16, 2022
• Last Updated: October 15, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)