Phase 3
N=834
A Trial to Reduce Pneumonia in Nursing Home Residents
Pneumonia · Lower Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT00975780 ↗Enrolled (actual)
834
Serious AEs
42.8%
Results posted
Jan 2014
Primary outcome: Primary: Pneumonia — 119; 94 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Enhanced Oral Care (Other); Usual oral care (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pneumonia |
119; 94 | — |
| SECONDARY Lower Respiratory Tract Infection Other Than Pneumonia |
125; 100 | — |
Summary
The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00975780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.