Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist

April 29, 2012 updated by: Masahiro Hatta, Yubari Kibounomori

The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Yubari, Hokkaido, Japan, 068-0402
        • Yubari Kibounomori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The residents or an agent who understand the purpose of this study and give informed consent.

Exclusion Criteria:

  • The residents contraindicated to vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral care and vaccines
Oral care and pneumococcal plus influenza vaccines
Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
  • Pneumovax NP
  • Serial Number: 21800AMY10131000
Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
  • Flubik HA
  • Serial Number: 16100EZZ01207000
Other: Specific frequency of oral care
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.
Other Names:
  • Not applicable:Behaviour
Active Comparator: Vaccine
Influenza vaccine only
Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
  • Flubik HA
  • Serial Number: 16100EZZ01207000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Pneumonia
Time Frame: 1 year
Number of Participants with Pneumonia sufferers
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death From Pneumonia
Time Frame: 1 year
Number of participants for the death from pneumonia
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leaving Nursing Home
Time Frame: These participants were followed for the duration of nursing home stay, an average of 22 weeks.
Numer of resident for leaving nursing home
These participants were followed for the duration of nursing home stay, an average of 22 weeks.
Reject Oral Care
Time Frame: This participant rejected oral care before treatment, Day 1
Number of resident to reject oral care
This participant rejected oral care before treatment, Day 1
Reject Vaccine
Time Frame: These participants rejected vaccine before treatment, Day 1
Number of resident to reject vaccine
These participants rejected vaccine before treatment, Day 1
Died Before Oral Care Starting
Time Frame: This participant was died before treatment, Day 1
Number of resident died before the start of oral care
This participant was died before treatment, Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yubari Kibounomori

Collaborators

Health Research Foundation

Investigators

  • Study Director: Hirofumi Hashimoto, M.D.,Ph.D., Yubari Health Care Research Center
  • Study Chair: Masahiro Hatta, D.D.S., Yubari Kibounomori
  • Study Director: Takahiro Ichiki, M.D., Mukawa town National Health Insurance Hobetsu clinic
  • Study Director: Katsushi Nagamori, M.D., Yubari Health Care Research Center
  • Principal Investigator: Hiroyuki Morita, M.D., Yubari Health Care Research Cente
  • Study Director: Masako Hatta, D.D.S., Yubari Health Care Research Center
  • Study Director: Tomohiko Murakami, M.D., Yubari Kibounomori

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 29, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 803121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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