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

This study has been completed.
Sponsor:
Collaborator:
Health Research Foundation
Information provided by (Responsible Party):
Masahiro Hatta, Yubari Kibounomori
ClinicalTrials.gov Identifier:
NCT01403805
First received: July 25, 2011
Last updated: April 29, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Pneumonia
Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)
Other: Specific frequency of oral care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yubari Kibounomori:

Primary Outcome Measures:
  • Number of Participants With Pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of Participants with Pneumonia sufferers


Secondary Outcome Measures:
  • Death From Pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participants for the death from pneumonia


Enrollment: 199
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403805

Locations
Japan
Yubari Kibounomori
Yubari, Hokkaido, Japan, 068-0402
Sponsors and Collaborators
Yubari Kibounomori
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
  More Information

No publications provided

Responsible Party: Masahiro Hatta, Dr., Yubari Kibounomori
ClinicalTrials.gov Identifier: NCT01403805     History of Changes
Other Study ID Numbers: 803121
Study First Received: July 25, 2011
Results First Received: August 2, 2011
Last Updated: April 29, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Yubari Kibounomori:
Oral care
Vaccine
Pneumonia
Elderly
Prevention
Primary care

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014