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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00975780
First received: September 10, 2009
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lower respiratory tract infection other than pneumonia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 834
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
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
  Contacts and Locations
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
National Institute on Aging (NIA)
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
Last Updated: December 14, 2012
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 May 19, 2013