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CompletedNCT03286790INCURUpdated Sep 18, 2017

Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents

An observational study in Pneumonia, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
60 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pneumonia

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Keywords

  • elderly
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients living in the participating EHPAD for more than 30 days since the baseline study visit

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No

Interventions

  • OtherData collection on pneumonia events
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: months 12

  2. 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

    Time frame: months 12

Secondary outcomes

  1. 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

    Time frame: Months 12

  2. 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

    Time frame: Months 12

06

Study locations

1 site
  • University Hospital Toulouse
    Toulouse, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03286790
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
May 2012
Primary completion
May 2016
Completion
May 2016
Last update
Sep 18, 2017

Study contacts

Mateo Cesari, MD
study director · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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