A Trial to Reduce Pneumonia in Nursing Home Residents

Pneumonia Clinical Trial

— PRIDE  

Official title:

A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975780
• Other study ID #: 0609001783
• Secondary ID: R01AG030575
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: November 7, 2014
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lower Respiratory Tract Infection
• Pneumonia
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia	The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.	2.5 years	No
Secondary	Lower Respiratory Tract Infection Other Than Pneumonia	The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.	2.5 years	No