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: December 6, 2013
Last verified: December 2013
Results First Received: December 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pneumonia
Lower Respiratory Tract Infection
Interventions: Other: Enhanced Oral Care
Other: Usual oral care

  Participant Flow
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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
  Description
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  
NOT COMPLETED     0     0  

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
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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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  434     400     834  
Age  
[units: years]
Mean ± Standard Deviation
  86.5  ± 8.0     86.1  ± 8.3     86.3  ± 8.1  
Gender  
[units: participants]
     
Female     329     307     636  
Male     105     93     198  



  Outcome Measures
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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
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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 information pertains to data collected through 10/25/2012- which was the official trial termination date.

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



  More Information
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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
e-mail: vincent.quagliarello@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00975780     History of Changes
Other Study ID Numbers: 0609001783, R01AG030575
Study First Received: September 10, 2009
Results First Received: December 6, 2013
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board