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

November 7, 2014 updated by: Yale University

A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

834

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumonia
Time Frame: 2.5 years
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0609001783
  • R01AG030575 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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