PneumoniaINCURNCT03286790
Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents
An observational study of Pneumonia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Data collection on pneumonia events
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to May 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living in the participating EHPAD for more than 30 days since the baseline study visit
Who may be able to join
- Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)
- Ability and willingness to participate to the study and to provide informed consent
- Agreement with the patient's physician about the enrolment to the study
Who cannot join
- Refusal of the EHPAD to participate
- Patients with severe disability (GIR 1)
- Patients with no evidence of functional impairment (GIR 6)
- Patients living in the participating EHPAD for less than 30 days since the baseline study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of pNeumonia and Related ConseqUences in Nursing Home
In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.
- Conditions
- Pneumonia
- Being tested
- Data collection on pneumonia events
- Keywords
- elderly
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on pneumonia eventsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumonia
Estimate the incidence of pneumonia events in a sample of 800 older patients living in 30 EHPADs over a period of 12 months
Measured: months 12
healthcare costs
To compare the healthcare costs of participants experiencing a pneumonia event versus those who will not in a random sample of 800 older patients living in 30 EHPADs over a period of 12 month
Measured: months 12
Secondary outcomes (2)
Mortality risk
To calculate the mortality risk in a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months
Measured: Months 12
Physical Function
To measure the physical function modifications experienced by a random sample of 800 EHPAD older patients according to the presence/absence of a pneumonia event occurred during a follow-up period of 12 months
Measured: Months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startMay 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mateo Cesari, MD, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286790
- Sponsor's protocol ID
- 11 280 03
- Acronym
- INCUR
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of pNeumonia and Related ConseqUences in Nursing Home
- ClinicalTrials.gov ID
- NCT03286790
- Acronym / sponsor ID
- INCUR / 11 280 03
- Conditions
- Pneumonia
- Keywords
- elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Sep 2017 (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.
In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living in the participating EHPAD for more than 30 days since the baseline study visit
Key inclusion criteria (3 listed)
- Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)
- Ability and willingness to participate to the study and to provide informed consent
- Agreement with the patient's physician about the enrolment to the study
Key exclusion criteria (4 listed)
- Refusal of the EHPAD to participate
- Patients with severe disability (GIR 1)
- Patients with no evidence of functional impairment (GIR 6)
- Patients living in the participating EHPAD for less than 30 days since the baseline study visit
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 |
|---|---|---|
| Data collection on pneumonia events | Other | – |
Primary outcome
Incidence of pneumonia
Time frame: months 12
Estimate the incidence of pneumonia events in a sample of 800 older patients living in 30 EHPADs over a period of 12 months
healthcare costs
Time frame: months 12
To compare the healthcare costs of participants experiencing a pneumonia event versus those who will not in a random sample of 800 older patients living in 30 EHPADs over a period of 12 month
2 secondary outcomes
Mortality risk
Time frame: Months 12
Physical Function
Time frame: Months 12
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 18 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Mateo Cesari, MD study director
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 Pneumonia, 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 3 inclusion and 4 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 18 Sep 2017. 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?
Incidence of pneumonia (time frame: months 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2017.