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OpenTrials
Completed

NCT Number: NCT03286790

Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Data collection on pneumonia events

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Mortality risk

    Time frame: Months 12

    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

  2. Physical Function

    Time frame: Months 12

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Incidence of pNeumonia and Related ConseqUences in Nursing Home

Acronym: INCUR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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