- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740658
Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents (PIANO-COVID-19)
Effect of Organizational Measures to Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents During and After the Epidemic Period
Study Overview
Detailed Description
The PIANO COVID-19 study is an observational, ambidirectional multicenter cohort study. The study will compare the death rates (COVID and non-COVID) in NHs according to the application of the general and specific recommendations of the region by the NH teams, taking into account the COVID infection rate in the NH department, the transfer capacities to hospitals, the medicalization of NH and the general characteristics of residents of NH. These parameters having been fluctuating over time, the analysis will also take into account the period considered.
3 sources of data will be used :
- Questionnaire: The NH team leaders will be asked to report variable related to the implementation of the recommendation/guidance by the nursing home staff, the general characteristics of the residents, and characteristics of the NH, and the monthly rate of death from January to December 2020.
A score will be built in regard to the implementation of the recommendation/guidance from the nursing home staff.
- Data related to the recommendations/guidance of the 13 regions of France (general guidance such as barriers measures and specificity guidance), the COVID infection rate in each NH department, the transfer capacities to hospitals and emergency department, will be collected by the PIANO COVID-19 research team.
For this purpose, referent teams for the COVID-19 outbreak of the each Regional Health Agency (RHA) of the 13 regions of France are contacted in order to recover the recommendation documents having been sent to the NHs.
- Official national data related to the COVID infection rate in the NH administrative region, and transfer capacities to hospitals, will be collected from open access website of the "Santé Publique France" website or other official websites currently providing these data. These data are updated on a daily basis for all administrative region of France and have been registered from the beginning of the outbreak.
- Qualitative study: To improve the understanding of the effects of the recommendations/guidance on resident's health, we will carry out a qualitative study with the NH staff of 20 public and private NH (half clusters NH for COVID-19 and half NH saved from COVID-19). Onsite semi-structured interviews will be conducted with the NH staff to better understand the subjective assessment of healthcare professional on the impact of the recommendations/guidance on the residents' health status. The main questions to which the interviews with the nurses and the nursing assistants will answer, will relate to the functional decline, the appetite and the nutritional status, the mood, the evolution of the cognitive capacities, their psycho-behavioral disturbances and their quality of life during the epidemic period. This qualitative survey will be carried out among NHs having been strongly impacted by the epidemic (NHs cluster with more than 20 deaths) and NHs having not at all been affected by the epidemic (no case of COVID-19 among residents or health care professional). The qualitative study will involve NHs located in very variable geographical regions in regards to the outbreak.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Toulouse, France, 31059
- University Hospital Toulouse - Gerontopole
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Within each NH, all NH residents living in the NH the 1st of January 2020 will be included.
Exclusion Criteria:
- NHs or Long Term Care Facilities (LTCFs) that refuse to participate.
- NHs that are not voluntary or not located in the regions and NHs that do not have a coordinating doctor .
- Within each NH, all NH residents not living in the NH or LTCFs the 1st of January 2020 will be not be included.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death occurrence within one year of follow up
Time Frame: from January 2020 to December 2020
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from January 2020 to December 2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
deaths related to COVID during the one-year follow-up
Time Frame: from January 2020 to December 2020
|
The secondary objective N°1 is to compare the rate of death related to confirmed or suspected COVID cases in NH with a high level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection and NH with a low level of implementation of the recommendation/guidance to prevent and control COVID-19 NH.
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from January 2020 to December 2020
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
deaths not related to COVID during the one-year follow-up
Time Frame: from January 2020 to December 2020
|
The secondary objective N°2 is to compare the rate of death not related to COVID cases in NH with a high level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection and NH with a low level of implementation of the recommendation/guidance to prevent and control COVID-19 NH.
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from January 2020 to December 2020
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evaluate the economic impact of the implementation of prevention measures
Time Frame: 6 and 12 months before and after the implementation of the preventive measures
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This secondary objective N°3 is to evaluate the economic impact of the implementation of prevention measures applied by nursing homes staff, from healthcare system and the NH perspectives. - Direct medical and non-medical costs 6 and 12 months before and after the high or low level implementation of recommendations to prevent and control COVID-19, using the Mandatory National Health Insurance database. |
6 and 12 months before and after the implementation of the preventive measures
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Health economic study: evaluate Direct medical and non-medical costs
Time Frame: 6 and 12 months before and after the implementation of the preventive measures
|
This secondary objective N°3 is to evaluate the economic impact of the implementation of prevention measures applied by nursing homes staff, from healthcare system and the NH perspectives. - Direct medical and non-medical costs rate to assess the cost-effectiveness of high-level implementation of recommendation to prevent and control COVID-19. |
6 and 12 months before and after the implementation of the preventive measures
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Health economic study: evaluate the mortality rate
Time Frame: 6 and 12 months before and after the implementation of the preventive measures
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This secondary objective N°3 is to evaluate the economic impact of the implementation of prevention measures applied by nursing homes staff, from healthcare system and the NH perspectives. - Mortality rate to assess the cost-effectiveness of high-level implementation of recommendation to prevent and control COVID-19. |
6 and 12 months before and after the implementation of the preventive measures
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/20/0300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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