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

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ClinicalTrials.gov Identifier: NCT01403805
Recruitment Status : Completed
First Posted : July 27, 2011
Results First Posted : May 1, 2012
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
Health Research Foundation
Information provided by (Responsible Party):
Masahiro Hatta, Yubari Kibounomori

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia Biological: Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000) Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000) Other: Specific frequency of oral care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Vaccines

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Pneumonia [ Time Frame: 1 year ]
    Number of Participants with Pneumonia sufferers


Secondary Outcome Measures :
  1. Death From Pneumonia [ Time Frame: 1 year ]
    Number of participants for the death from pneumonia


Other Outcome Measures:
  1. 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

  2. Reject Oral Care [ Time Frame: This participant rejected oral care before treatment, Day 1 ]
    Number of resident to reject oral care

  3. Reject Vaccine [ Time Frame: These participants rejected vaccine before treatment, Day 1 ]
    Number of resident to reject vaccine

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403805


Locations
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Japan
Yubari Kibounomori
Yubari, Hokkaido, Japan, 068-0402
Sponsors and Collaborators
Yubari Kibounomori
Health Research Foundation
Investigators
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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
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Responsible Party: Masahiro Hatta, Dr., Yubari Kibounomori
ClinicalTrials.gov Identifier: NCT01403805    
Other Study ID Numbers: 803121
First Posted: July 27, 2011    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: May 1, 2012
Last Verified: April 2012
Keywords provided by Masahiro Hatta, Yubari Kibounomori:
Oral care
Vaccine
Pneumonia
 Elderly
Prevention
Primary care
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
 Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs