Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
834 participants
INTERVENTIONAL
2009-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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enhanced oral care
Enhanced Oral Care
oral brushing plus oral chlorhexidine plus upright feeding positioning
Usual care
The usual oral care provided at the nursing home
Usual oral care
Usual oral care and feeding positioning
Interventions
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Enhanced Oral Care
oral brushing plus oral chlorhexidine plus upright feeding positioning
Usual oral care
Usual oral care and feeding positioning
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Vincent J Quagliarello, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Mary Tinetti, MD
Role: STUDY_DIRECTOR
Yale University
Manisha Juthani-Mehta, MD
Role: STUDY_DIRECTOR
Yale University
Peter Peduzzi, PhD
Role: STUDY_DIRECTOR
Yale University
Dorothy Baker, PhD
Role: STUDY_DIRECTOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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References
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Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16.
Other Identifiers
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0609001783
Identifier Type: -
Identifier Source: org_study_id