A Trial to Reduce Pneumonia in Nursing Home Residents

Overview

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

Full Title of Study: “A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2012

Interventions

  • Other: Enhanced Oral Care
    • oral brushing plus oral chlorhexidine plus upright feeding positioning
  • Other: Usual oral care
    • Usual oral care and feeding positioning

Arms, Groups and Cohorts

  • Experimental: enhanced oral care
  • Active Comparator: Usual care
    • The usual oral care provided at the nursing home

Clinical Trial Outcome Measures

Primary Measures

  • Pneumonia
    • Time Frame: 2.5 years
    • The number of participants that recorded a ‘first pneumonia’ during the 2.5 years timeframe.

Secondary Measures

  • Lower Respiratory Tract Infection Other Than Pneumonia
    • Time Frame: 2.5 years
    • The number of participants that recorded a ‘lower respiratory tract infection other than pneumonia’ during the 2.5 years timeframe.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vincent J Quagliarello, MD, Principal Investigator, Yale University
    • Mary Tinetti, MD, Study Director, Yale University
    • Manisha Juthani-Mehta, MD, Study Director, Yale University
    • Peter Peduzzi, PhD, Study Director, Yale University
    • Dorothy Baker, PhD, Study Director, Yale University

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