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A Trial to Reduce Pneumonia in Nursing Home Residents (PRIDE)

Primary Purpose

Pneumonia, Lower Respiratory Tract Infection

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Enhanced Oral Care

Usual oral care

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

enhanced oral care

Usual care

Arm Description

The usual oral care provided at the nursing home

Outcomes

Primary Outcome Measures

Pneumonia

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00975780

First Posted

September 10, 2009

Last Updated

November 7, 2014

Sponsor

Yale University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00975780

Brief Title

A Trial to Reduce Pneumonia in Nursing Home Residents

Acronym

PRIDE

Official Title

A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Lower Respiratory Tract Infection

Keywords

Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

834 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enhanced oral care

Arm Type

Experimental

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

The usual oral care provided at the nursing home

Intervention Type

Other

Intervention Name(s)

Enhanced Oral Care

Intervention Description

oral brushing plus oral chlorhexidine plus upright feeding positioning

Intervention Type

Other

Intervention Name(s)

Usual oral care

Intervention Description

Usual oral care and feeding positioning

Primary Outcome Measure Information:

Title

Pneumonia

Description

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

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

Lower Respiratory Tract Infection Other Than Pneumonia

Description

The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.

Time Frame

2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials: