Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino) (Mon-Covid)
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|ClinicalTrials.gov Identifier: NCT04361916|
Recruitment Status : Terminated (interrupted early due to the drastic reduction in the number of cases)
First Posted : April 24, 2020
Last Update Posted : September 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Other: home care monitoring||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single arm, open label trial on active home monitoring strategy|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)|
|Actual Study Start Date :||April 21, 2020|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||June 30, 2020|
Experimental: home care with active monitoring
home care with active monitoring conducted by health workers with daily visit to patients.
Other: home care monitoring
home care active monitoring of patients with suspected of confirmed COVID-19
- SpO2 at hospital entry [ Time Frame: 24 hours ]Peripheral blood saturation measured on arrival to the hospital
- in-hospital mortality [ Time Frame: 30 days ]death during hospitalization
- need of intubation [ Time Frame: 30 days ]need of intubation
- Percentage of hospitalized patients among those with recommendation of hospitalization [ Time Frame: 30 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361916
|Casale Monferrato, Alessandria, Italy|
|Principal Investigator:||Guido Bertolini, MD||Mario Negri Institute for Pharmacological Research|