Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)

Study Overview
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Brief Summary
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Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care. Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

Detailed Description
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The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate. Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count. Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2< 90% OR SpO2> 90% with desaturation index of at least 5% at Quick Walk Test)

Official Title
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Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)

Conditions
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COVID-19

Intervention / Treatment
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* Other: home care monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate. Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: single arm, open label trial on active home monitoring strategy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home care with active monitoring<br>home care with active monitoring conducted by health workers with daily visit to patients. | Other: home care monitoring<br>* home care active monitoring of patients with suspected of confirmed COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 at hospital entry | Peripheral blood saturation measured on arrival to the hospital | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality | death during hospitalization | 30 days | 
| need of intubation | need of intubation | 30 days | 
| Percentage of hospitalized patients among those with recommendation of hospitalization | To evaluate the feasibility of active monitoring, we will consider the percentage of patients who will be actually hospitalized within 24 hours after the recommendation of hospitalization | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, oximetry, active monitoring, home care