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A Trial to Reduce Pneumonia in Nursing Home Residents (PRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975780
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 21, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumonia Lower Respiratory Tract Infection Other: Enhanced Oral Care Other: Usual oral care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 834 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents
Study Start Date : October 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: enhanced oral care Other: Enhanced Oral Care
oral brushing plus oral chlorhexidine plus upright feeding positioning
Active Comparator: Usual care
The usual oral care provided at the nursing home
 Other: Usual oral care
Usual oral care and feeding positioning


Outcome Measures
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Primary Outcome Measures :
  1. Pneumonia [ Time Frame: 2.5 years ]
    The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.


Secondary Outcome Measures :
  1. Lower Respiratory Tract Infection Other Than Pneumonia [ Time Frame: 2.5 years ]
    The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975780


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Vincent J Quagliarello, MD Yale University
Study Director: Mary Tinetti, MD Yale University
Study Director: Manisha Juthani-Mehta, MD Yale University
Study Director: Peter Peduzzi, PhD Yale University
Study Director: Dorothy Baker, PhD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00975780    
Other Study ID Numbers: 0609001783
R01AG030575 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2009    Key Record Dates
Results First Posted: January 21, 2014
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Yale University:
Pneumonia
Lower respiratory tract infection
Lower respiratory tract infection other than pneumonia
Additional relevant MeSH terms:
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Infections
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases