NCT01403805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 1, 2012

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

July 25, 2011

Results QC Date

August 2, 2011

Last Update Submit

April 29, 2012

Conditions

Pneumonia

Keywords

Oral careVaccinePneumoniaElderlyPreventionPrimary care

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Pneumonia

    Number of Participants with Pneumonia sufferers

    1 year

Secondary Outcomes (1)

  • Death From Pneumonia

    1 year

Other Outcomes (4)

  • Leaving Nursing Home

    These participants were followed for the duration of nursing home stay, an average of 22 weeks.

  • Reject Oral Care

    This participant rejected oral care before treatment, Day 1

  • Reject Vaccine

    These participants rejected vaccine before treatment, Day 1

  • +1 more other outcomes

Study Arms (2)

Oral care and vaccines

EXPERIMENTAL

Oral care and pneumococcal plus influenza vaccines

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

Vaccine

ACTIVE COMPARATOR

Influenza vaccine only

Biological: Influenza vaccination (Flubik HA, 16100EZZ01207000)

Interventions

Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)BIOLOGICAL

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

Also known as: Pneumovax NP, Serial Number: 21800AMY10131000
Oral care and vaccines
Influenza vaccination (Flubik HA, 16100EZZ01207000)BIOLOGICAL

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

Also known as: Flubik HA, Serial Number: 16100EZZ01207000
Oral care and vaccines
Specific frequency of oral careOTHER

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.

Also known as: Not applicable:Behaviour
Oral care and vaccines

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The residents contraindicated to vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yubari Kibounomori

Yūbari, Hokkaido, 068-0402, Japan

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Limitations and Caveats

small numbers of subjects analyzed

Results Point of Contact

Title
Dr. Masahiro Hatta
Organization
Department of Dentistry, Yubari Kibounomori, Japan
masahiro.hatta@hotmail.co.jp
+81-123-52-4339

Study Officials

  • Hirofumi Hashimoto, M.D.,Ph.D.

    Yubari Health Care Research Center

    STUDY DIRECTOR

  • Masahiro Hatta, D.D.S.

    Yubari Kibounomori

    STUDY CHAIR

  • Takahiro Ichiki, M.D.

    Mukawa town National Health Insurance Hobetsu clinic

    STUDY DIRECTOR

  • Katsushi Nagamori, M.D.

    Yubari Health Care Research Center

    STUDY DIRECTOR

  • Hiroyuki Morita, M.D.

    Yubari Health Care Research Cente

    PRINCIPAL INVESTIGATOR

  • Masako Hatta, D.D.S.

    Yubari Health Care Research Center

    STUDY DIRECTOR

  • Tomohiko Murakami, M.D.

    Yubari Kibounomori

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 27, 2011

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 1, 2012

Results First Posted

May 1, 2012

Record last verified: 2012-04

Locations

JP(1)