Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist
April 29, 2012 updated by: Masahiro Hatta, Yubari Kibounomori
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
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
199
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hokkaido
-
Yubari, Hokkaido, Japan, 068-0402
- Yubari Kibounomori
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oral care and vaccines
Oral care and pneumococcal plus influenza vaccines
|
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
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 Names:
|
|
Active Comparator: Vaccine
Influenza vaccine only
|
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Pneumonia
Time Frame: 1 year
|
Number of Participants with Pneumonia sufferers
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Death From Pneumonia
Time Frame: 1 year
|
Number of participants for the death from pneumonia
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
These participants were followed for the duration of nursing home stay, an average of 22 weeks.
|
|
Reject Oral Care
Time Frame: This participant rejected oral care before treatment, Day 1
|
Number of resident to reject oral care
|
This participant rejected oral care before treatment, Day 1
|
|
Reject Vaccine
Time Frame: These participants rejected vaccine before treatment, Day 1
|
Number of resident to reject vaccine
|
These participants rejected vaccine before treatment, Day 1
|
|
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
|
This participant was died before treatment, Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
July 25, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (Estimate)
July 27, 2011
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 29, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 803121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.