Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents

Pneumonia Clinical Trial

— INCUR  

Official title:

Incidence of pNeumonia and Related ConseqUences in Nursing Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286790
• Other study ID #: 11 280 03
• Status: Completed
• Phase: N/A
• First received: September 14, 2017
• Last updated: September 14, 2017
• Start date: May 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• Data collection on pneumonia events

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	months 12
Primary	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	months 12
Secondary	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	Months 12
Secondary	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	Months 12