Back to resultsEffects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Influenza vaccination (Flubik HA, 16100EZZ01207000)
Influenza vaccination (Flubik HA, 16100EZZ01207000)
Specific frequency of oral care
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia focused on measuring Oral care, Vaccine, Pneumonia, Elderly, Prevention, Primary care
Eligibility 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
Sites / Locations
- Yubari Kibounomori
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral care and vaccines
Vaccine
Arm Description
Oral care and pneumococcal plus influenza vaccines
Influenza vaccine only
Outcomes
Primary Outcome Measures
Number of Participants With Pneumonia
Number of Participants with Pneumonia sufferers
Secondary Outcome Measures
Death From Pneumonia
Number of participants for the death from pneumonia
Full Information
NCT ID
NCT01403805
First Posted
July 25, 2011
Last Updated
April 29, 2012
Sponsor
Yubari Kibounomori
Collaborators
Health Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01403805
Brief Title
Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yubari Kibounomori
Collaborators
Health Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Oral care, Vaccine, Pneumonia, Elderly, Prevention, Primary care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral care and vaccines
Arm Type
Experimental
Arm Description
Oral care and pneumococcal plus influenza vaccines
Arm Title
Vaccine
Arm Type
Active Comparator
Arm Description
Influenza vaccine only
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Other Intervention Name(s)
Pneumovax NP, Serial Number: 21800AMY10131000
Intervention Description
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination (Flubik HA, 16100EZZ01207000)
Other Intervention Name(s)
Flubik HA, Serial Number: 16100EZZ01207000
Intervention Description
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination (Flubik HA, 16100EZZ01207000)
Other Intervention Name(s)
Flubik HA, Serial Number: 16100EZZ01207000
Intervention Description
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Intervention Type
Other
Intervention Name(s)
Specific frequency of oral care
Other Intervention Name(s)
Not applicable:Behaviour
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Pneumonia
Description
Number of Participants with Pneumonia sufferers
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death From Pneumonia
Description
Number of participants for the death from pneumonia
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Leaving Nursing Home
Description
Numer of resident for leaving nursing home
Time Frame
These participants were followed for the duration of nursing home stay, an average of 22 weeks.
Title
Reject Oral Care
Description
Number of resident to reject oral care
Time Frame
This participant rejected oral care before treatment, Day 1
Title
Reject Vaccine
Description
Number of resident to reject vaccine
Time Frame
These participants rejected vaccine before treatment, Day 1
Title
Died Before Oral Care Starting
Description
Number of resident died before the start of oral care
Time Frame
This participant was died before treatment, Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirofumi Hashimoto, M.D.,Ph.D.
Organizational Affiliation
Yubari Health Care Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Masahiro Hatta, D.D.S.
Organizational Affiliation
Yubari Kibounomori
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Takahiro Ichiki, M.D.
Organizational Affiliation
Mukawa town National Health Insurance Hobetsu clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katsushi Nagamori, M.D.
Organizational Affiliation
Yubari Health Care Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hiroyuki Morita, M.D.
Organizational Affiliation
Yubari Health Care Research Cente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Masako Hatta, D.D.S.
Organizational Affiliation
Yubari Health Care Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tomohiko Murakami, M.D.
Organizational Affiliation
Yubari Kibounomori
Official's Role
Study Director
Facility Information:
Facility Name
Yubari Kibounomori
City
Yubari
State/Province
Hokkaido
ZIP/Postal Code
068-0402
Country
Japan
12. IPD Sharing Statement
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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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