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Completed

NCT Number: NCT00975780

A 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.

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Key information

Conditions

Pneumonia Infections Lower Respiratory Tract Infection Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Oral Care

Other

oral brushing plus oral chlorhexidine plus upright feeding positioning

Usual oral care

Other

Usual oral care and feeding positioning

Primary outcomes

  1. Pneumonia

    Time frame: 2.5 years

    The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

Acronym: PRIDE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 11, 2009
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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