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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 834
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975780

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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

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

Keywords provided by Yale University:
Pneumonia
Lower respiratory tract infection
Lower respiratory tract infection other than pneumonia

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on August 28, 2014