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. Identifier: NCT00975780
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 21, 2014
Last Update Posted : November 20, 2014
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pneumonia
Lower Respiratory Tract Infection
Interventions: Other: Enhanced Oral Care
Other: Usual oral care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Usual Care

The usual oral care provided at the nursing home

Usual oral care : Usual oral care and feeding positioning

Enhanced Oral Care Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning

Participant Flow for 2 periods

Period 1:   Allocation
    Usual Care   Enhanced Oral Care
STARTED   400   434 
COMPLETED   400   434 

Period 2:   Follow Up
    Usual Care   Enhanced Oral Care
STARTED   400   434 
COMPLETED   298   277 
NOT COMPLETED   102   157 
Death                88                122 
Facility Withdrawal                7                23 
Discharged from Facility                7                12 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Enhanced Oral Care Study participants receiving 'Enhanced Oral Care' in the study
Usual Oral Care Study participants receiving 'Usual Oral Care' in the study.
Total Total of all reporting groups

Baseline Measures
   Enhanced Oral Care   Usual Oral Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 434   400   834 
[Units: Years]
Mean (Standard Deviation)
 86.5  (8.0)   86.1  (8.3)   86.3  (8.1) 
[Units: Participants]
Female   329   307   636 
Male   105   93   198 

  Outcome Measures

1.  Primary:   Pneumonia   [ Time Frame: 2.5 years ]

2.  Secondary:   Lower Respiratory Tract Infection Other Than Pneumonia   [ Time Frame: 2.5 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Participant flow and outcome information pertains to data collected through 10/25/2012- the official trial termination date.

Serious and Other Adverse Event information pertains to requested surveillance of subjects through 12/10/2012 per the NIA.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Vincent James Quagliarello MD, Professor of Medicine (Infectious Diseases); Clinical Chief, Infectio
Organization: Yale University School of Medicine
phone: (203) 785-7571

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Yale University Identifier: NCT00975780     History of Changes
Other Study ID Numbers: 0609001783
R01AG030575 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: December 6, 2013
Results First Posted: January 21, 2014
Last Update Posted: November 20, 2014