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

NCT ID: NCT01403805

Last Updated: 2012-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral care and vaccines

Oral care and pneumococcal plus influenza vaccines

Group Type EXPERIMENTAL

Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)

Intervention Type BIOLOGICAL

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Influenza vaccination (Flubik HA, 16100EZZ01207000)

Intervention Type BIOLOGICAL

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Specific frequency of oral care

Intervention Type OTHER

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.

Vaccine

Influenza vaccine only

Group Type ACTIVE_COMPARATOR

Influenza vaccination (Flubik HA, 16100EZZ01207000)

Intervention Type BIOLOGICAL

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Interventions

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Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Intervention Type BIOLOGICAL

Influenza vaccination (Flubik HA, 16100EZZ01207000)

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Intervention Type BIOLOGICAL

Influenza vaccination (Flubik HA, 16100EZZ01207000)

Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

Other Intervention Names

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Pneumovax NP Serial Number: 21800AMY10131000 Flubik HA Serial Number: 16100EZZ01207000 Flubik HA Serial Number: 16100EZZ01207000 Not applicable:Behaviour

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Research Foundation

OTHER

Sponsor Role collaborator

Yubari Kibounomori

OTHER

Sponsor Role lead

Responsible Party

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Masahiro Hatta

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hirofumi Hashimoto, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Yubari Health Care Research Center

Masahiro Hatta, D.D.S.

Role: STUDY_CHAIR

Yubari Kibounomori

Takahiro Ichiki, M.D.

Role: STUDY_DIRECTOR

Mukawa town National Health Insurance Hobetsu clinic

Katsushi Nagamori, M.D.

Role: STUDY_DIRECTOR

Yubari Health Care Research Center

Hiroyuki Morita, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yubari Health Care Research Cente

Masako Hatta, D.D.S.

Role: STUDY_DIRECTOR

Yubari Health Care Research Center

Tomohiko Murakami, M.D.

Role: STUDY_DIRECTOR

Yubari Kibounomori

Locations

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Yubari Kibounomori

Yūbari, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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803121

Identifier Type: -

Identifier Source: org_study_id

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