A Trial to Reduce Pneumonia in Nursing Home Residents

Phase 3

Completed

• Conditions: Pneumonia; Lower Respiratory Tract Infection
• Interventions: Other: Enhanced Oral Care; Other: Usual oral care

• Registration Number: NCT00975780
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2009-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-12-06
• Results First Submitted QC: 2013-12-06
• Results First Posted: 2014-01-21
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

Inclusion Criteria

• long term care resident of nursing home
• residents age >65
• residents of nursing home for at least one month
• residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty)

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Exclusion Criteria

• residents housed in nursing home for short term rehabilitation
• residents who receive nourishment by tube feeding
• residents who have a life expectancy < 3 months
• residents who have been diagnosed with pneumonia within the previous 6 weeks
• residents who are currently using oral chlorhexidine
• residents who have previously been enrolled in the study
• residents, or their designated proxies, who are unwilling to give informed consent
• residents who have tracheostomy
• residents who are non-english speaking
• residents who the administrator leadership of the home felt were not appropriate for the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced oral care	Enhanced Oral Care	-
Usual care	Usual oral care	The usual oral care provided at the nursing home

Primary Outcome Measures

Name	Time	Method
Pneumonia	2.5 years	The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.

Secondary Outcome Measures

Name	Time	Method
Lower Respiratory Tract Infection Other Than Pneumonia	2.5 years	The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States