Back to resultsHome Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino) (Mon-Covid)
Primary Purpose
COVID-19
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
home care monitoring
Sponsored by
About this trial
This is an interventional health services research trial for COVID-19 focused on measuring COVID-19, oximetry, active monitoring, home care
Eligibility Criteria
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
Sites / Locations
- Asl Alessandria
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
home care with active monitoring
Arm Description
home care with active monitoring conducted by health workers with daily visit to patients.
Outcomes
Primary Outcome Measures
SpO2 at hospital entry
Peripheral blood saturation measured on arrival to the hospital
Secondary Outcome Measures
in-hospital mortality
death during hospitalization
need of intubation
need of intubation
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
Full Information
NCT ID
NCT04361916
First Posted
April 14, 2020
Last Updated
September 10, 2020
Sponsor
Mario Negri Institute for Pharmacological Research
1. Study Identification
Unique Protocol Identification Number
NCT04361916
Brief Title
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Acronym
Mon-Covid
Official Title
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
interrupted early due to the drastic reduction in the number of cases
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, oximetry, active monitoring, home care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm, open label trial on active home monitoring strategy
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
home care with active monitoring
Arm Type
Experimental
Arm Description
home care with active monitoring conducted by health workers with daily visit to patients.
Intervention Type
Other
Intervention Name(s)
home care monitoring
Intervention Description
home care active monitoring of patients with suspected of confirmed COVID-19
Primary Outcome Measure Information:
Title
SpO2 at hospital entry
Description
Peripheral blood saturation measured on arrival to the hospital
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
in-hospital mortality
Description
death during hospitalization
Time Frame
30 days
Title
need of intubation
Description
need of intubation
Time Frame
30 days
Title
Percentage of hospitalized patients among those with recommendation of hospitalization
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Bertolini, MD
Organizational Affiliation
Mario Negri Institute for Pharmacological Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asl Alessandria
City
Casale Monferrato
State/Province
Alessandria
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be available from the study sponsor upon legitimate request
Learn more about this trial
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)
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