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NCT00975780 Clinical Trial

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

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
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