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

NCT ID: NCT04361916

Last Updated: 2020-09-14

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-21

Study Completion Date

2020-06-30

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)

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm, open label trial on active home monitoring strategy
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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home care with active monitoring

home care with active monitoring conducted by health workers with daily visit to patients.

Group Type EXPERIMENTAL

home care monitoring

Intervention Type OTHER

home care active monitoring of patients with suspected of confirmed COVID-19

Interventions

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home care monitoring

home care active monitoring of patients with suspected of confirmed COVID-19

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guido Bertolini, MD

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research

Locations

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Asl Alessandria

Casale Monferrato, Alessandria, Italy

Site Status

Countries

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Italy

Other Identifiers

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Mon-Covid

Identifier Type: -

Identifier Source: org_study_id

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