Covid19PIANO-COVID-19NCT04740658
Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents
An observational study of Covid19, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The COVID epidemic has shown very high mortality among older people, especially among poly-morbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 12,166 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NH volunteers located in different regions more or less affected by the epidemic and NH coordinating physician/directors of NHs via the SFGG website, directors of large private groups (Korian, Orpea, Edenis, DOMUS-vi ..) or public groups (APHP), regional (FMC Gériatres 31) and national (FFAMCO) NH coordinating physician associations (FFAMCO, MCOOR), the referents geriatricians of large cities that have been particularly exposed to the epidemic (Mulhouse, Strasbourg, Paris) or particularly least exposed (Bordeaux, Brest).
Who may be able to join
- Within each NH, all NH residents living in the NH the 1st of January 2020 will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The COVID epidemic has shown very high mortality among older people, especially among poly-morbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible viral epidemic. In France, according to the Direction of research, studies, evaluation and statistics (DREES) data (Ehpa study, 2015) more than 600,000 elderly people currently live in nursing homes (NH). Since March 28, a national guidance for monitoring the COVID epidemic in NH has just been set up. In France, 14 178 of the 29 319 COVID deaths (48.35%) by June 10th 2020 occurred among NHs residents. Work to consolidate these data is underway, suggesting a much heavier balance sheet. Faced to this threat, in addition to practical recommendations (barrier protection gestures), strict instructions were also announced to all NH to keep their residents safe from COVID : restricting all visitors, all volunteers and nonessential personnel, and more recently, confining residents in their room in case of incident case of COVID in the NH. Organizational factors of NH such as the prevention strategies deployed before and during the epidemic (pneumococcal vaccination, restricting group activities), as well as NH internal resources (equipment, nursing staff) and health resources in the NH environment (hospital partnerships, support devices, telemedicine) lead to heterogeneous situations and could influence the death rates of residents. On the other hand, social isolation can also precipitate the decline of fragile residents. Beyond the immediate and directly risks linked to COVID-19, the present hypothesize that the organizational measures (guidance and recommendations) put in place can have, during and at a distance from the outbreak, beneficial effects but also deleterious effects depending on the severity of the outbreak of a geographic area. More precisely, the hypothesis is that strong and well-followed recommendations at the time of the epidemic were associated with a reduction in the risk of total death in particular of deaths related to COVID in the zones most affected by the epidemic but also that strong and well-followed recommendations were associated with an increased risk of total death, in particular of deaths unrelated to COVID in the areas least affected by the epidemic.
Read the 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.
- Conditions
- Covid19
- Being tested
- No intervention
- Keywords
- epidemic period, nursing homes, mortality, restriction measures impact, beneficial effects, deleterious effects
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Death occurrence within one year of follow up
- Primary criteria is death occurrence within one year of follow up: death rates will be recorded.
- Level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection will be score 14 days before the peak wave of the outbreak in the geographic area of each NH.
Measured: from January 2020 to December 2020
Secondary outcomes (1)
deaths related to COVID during the one-year follow-up
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.
Measured: from January 2020 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start8 Jul 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROLLAND, MD, PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740658
- Sponsor's protocol ID
- RC31/20/0300
- Acronym
- PIANO-COVID-19
- Status last verified
- Dec 2025
- First submitted
- 28 Jan 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rolland Y, Pennetier D, Shourick J, Barreto PS, Mathieu C, Blain H, Balandier C, Bonin-Guillaume S, Durel G, Gavazzi G, Guion V, Guerin O, Hanon O, Jeandel C, Jouatel L, Maubourguet N, Orvoen G, Passadori Y, Renoux A, Roubaud-Baudron C, Roussillon Soyer C, Salles N, Tabue-Teguo M, Villars H, Andrieu S. Association between strategies to prevent COVID-19 infection in long-term care facilities and mortality: the PIANO-COVID-19 study, a French multicentre cohort study. BMJ Public Health. 2025 Jun 20;3(1):e002156. doi: 10.1136/bmjph-2024-002156. eCollection 2025.
PubMed 40551971
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04740658
- Acronym / sponsor ID
- PIANO-COVID-19 / RC31/20/0300
- Conditions
- Covid19
- Keywords
- epidemic period, nursing homes, mortality, restriction measures impact, beneficial effects, deleterious effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,166 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID epidemic has shown very high mortality among older people, especially among poly-morbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible viral epidemic. In France, according to the Direction of research, studies, evaluation and statistics (DREES) data (Ehpa study, 2015) more than 600,000 elderly people currently live in nursing homes (NH). Since March 28, a national guidance for monitoring the COVID epidemic in NH has just been set up. In France, 14 178 of the 29 319 COVID deaths (48.35%) by June 10th 2020 occurred among NHs residents. Work to consolidate these data is underway, suggesting a much heavier balance sheet. Faced to this threat, in addition to practical recommendations (barrier protection gestures), strict instructions were also announced to all NH to keep their residents safe from COVID : restricting all visitors, all volunteers and nonessential personnel, and more recently, confining residents in their room in case of incident case of COVID in the NH. Organizational factors of NH such as the prevention strategies deployed before and during the epidemic (pneumococcal vaccination, restricting group activities), as well as NH internal resources (equipment, nursing staff) and health resources in the NH environment (hospital partnerships, support devices, telemedicine) lead to heterogeneous situations and could influence the death rates of residents. On the other hand, social isolation can also precipitate the decline of fragile residents. Beyond the immediate and directly risks linked to COVID-19, the present hypothesize that the organizational measures (guidance and recommendations) put in place can have, during and at a distance from the outbreak, beneficial effects but also deleterious effects depending on the severity of the outbreak of a geographic area. More precisely, the hypothesis is that strong and well-followed recommendations at the time of the epidemic were associated with a reduction in the risk of total death in particular of deaths related to COVID in the zones most affected by the epidemic but also that strong and well-followed recommendations were associated with an increased risk of total death, in particular of deaths unrelated to COVID in the areas least affected by the epidemic.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NH volunteers located in different regions more or less affected by the epidemic and NH coordinating physician/directors of NHs via the SFGG website, directors of large private groups (Korian, Orpea, Edenis, DOMUS-vi ..) or public groups (APHP), regional (FMC Gériatres 31) and national (FFAMCO) NH coordinating physician associations (FFAMCO, MCOOR), the referents geriatricians of large cities that have been particularly exposed to the epidemic (Mulhouse, Strasbourg, Paris) or particularly least exposed (Bordeaux, Brest).
Key inclusion criteria (1 listed)
- Within each NH, all NH residents living in the NH the 1st of January 2020 will be included.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention | Other | – |
Primary outcome
Death occurrence within one year of follow up
Time frame: from January 2020 to December 2020
* Primary criteria is death occurrence within one year of follow up: death rates will be recorded. * Level of implementation of the recommendation/guidance to prevent and control COVID-19 NH residents' infection will be score 14 days before the peak wave of the outbreak in the geographic area of each NH.
1 secondary outcome
deaths related to COVID during the one-year follow-up
Time frame: from January 2020 to December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 40551971Rolland Y, Pennetier D, Shourick J, Barreto PS, Mathieu C, Blain H, Balandier C, Bonin-Guillaume S, Durel G, Gavazzi G, Guion V, Guerin O, Hanon O, Jeandel C, Jouatel L, Maubourguet N, Orvoen G, Passadori Y, Renoux A, Roubaud-Baudron C, Roussillon Soyer C, Salles N, Tabue-Teguo M, Villars H, Andrieu S. Association between strategies to prevent COVID-19 infection in long-term care facilities and mortality: the PIANO-COVID-19 study, a French multicentre cohort study. BMJ Public Health. 2025 Jun 20;3(1):e002156. doi: 10.1136/bmjph-2024-002156. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves ROLLAND, MD, PHD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death occurrence within one year of follow up (time frame: from January 2020 to December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.