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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00975780
First received: September 10, 2009
Last updated: November 7, 2014
Last verified: November 2014

September 10, 2009
November 7, 2014
October 2009
December 2012   (final data collection date for primary outcome measure)
Pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
Pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00975780 on ClinicalTrials.gov Archive Site
Lower Respiratory Tract Infection Other Than Pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.
Lower respiratory tract infection other than pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial to Reduce Pneumonia in Nursing Home Residents
A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Pneumonia
  • Lower Respiratory Tract Infection
  • Other: Enhanced Oral Care
    oral brushing plus oral chlorhexidine plus upright feeding positioning
  • Other: Usual oral care
    Usual oral care and feeding positioning
  • Experimental: enhanced oral care
    Intervention: Other: Enhanced Oral Care
  • Active Comparator: Usual care
    The usual oral care provided at the nursing home
    Intervention: Other: Usual oral care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
834
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975780
0609001783, R01AG030575
Yes
Yale University
Yale University
National Institute on Aging (NIA)
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
Yale University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP