NCT00975780

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
834

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

September 10, 2009

Results QC Date

December 6, 2013

Last Update Submit

November 7, 2014

Conditions

PneumoniaLower Respiratory Tract Infection

Keywords

PneumoniaLower respiratory tract infectionLower respiratory tract infection other than pneumonia

Outcome Measures

Primary Outcomes (1)

  • Pneumonia

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

    2.5 years

Secondary Outcomes (1)

  • Lower Respiratory Tract Infection Other Than Pneumonia

    2.5 years

Study Arms (2)

enhanced oral care

EXPERIMENTAL
Other: Enhanced Oral Care

Usual care

ACTIVE COMPARATOR

The usual oral care provided at the nursing home

Other: Usual oral care

Interventions

Enhanced Oral CareOTHER

oral brushing plus oral chlorhexidine plus upright feeding positioning

enhanced oral care
Usual oral careOTHER

Usual oral care and feeding positioning

Usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16.

    PMID: 25520333DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Participant flow and outcome information pertains to data collected through 10/25/2012- the official trial termination date. Serious and Other Adverse Event information pertains to requested surveillance of subjects through 12/10/2012 per the NIA.

Results Point of Contact

Title
Vincent James Quagliarello MD, Professor of Medicine (Infectious Diseases); Clinical Chief, Infectio
Organization
Yale University School of Medicine
vincent.quagliarello@yale.edu
(203) 785-7571

Study Officials

  • Vincent J Quagliarello, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 20, 2014

Results First Posted

January 21, 2014

Record last verified: 2014-11

Locations

US(1)