UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013119 |
|---|---|
| Receipt number | R000014507 |
| Scientific Title | Research on the Roles of Oral Care and Nutrition Support in the Prevention of Aspiration Pneumonia (supported by the Health and Labour Sciences Research Grants program) |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2015/08/10 18:39:38 |
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Basic information
Public title
Research on the Roles of Oral Care and Nutrition Support in the Prevention of Aspiration Pneumonia (supported by the Health and Labour Sciences Research Grants program)
Acronym
Research on the Roles of Oral Care and Nutrition Support in the Prevention of Aspiration Pneumonia
Scientific Title
Research on the Roles of Oral Care and Nutrition Support in the Prevention of Aspiration Pneumonia (supported by the Health and Labour Sciences Research Grants program)
Scientific Title:Acronym
Research on the Roles of Oral Care and Nutrition Support in the Prevention of Aspiration Pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Neurology | Infectious disease |
| Geriatrics | Dental medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research project will examine the benefits of nutrition support and final cleaning following oral care. A group at high risk for aspiration pneumonia will be selected based on risk factors identified in previous studies. The ultimate objective is to analyze the incidence of aspiration pneumonia and other endpoints in the intervention and control groups to generate data for use in making proposals or creating a manual for preventing aspiration pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of pneumonia
Key secondary outcomes
Body measurements, blood biochemical data, comorbidity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Maneuver |
Interventions/Control_1
In addition to providing daily oral care, a facility employee (e.g., nurse) will clean the mouth of each subject with a moist towelette for oral cleaning to remove oral bacteria.
Interventions/Control_2
In addition to regular meals, each subject will be given two dietary supplements (each providing about 80 to 100 kcal/day and 5 to 10 g/day of protein).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with poor nutritional status (body mass index <18.5 and serum albumin <3.5 g/dL)
Subjects with dysphagia to an extent that allows oral consumption (i.e., a thickener must be added to tea and other beverages, requires at least 30 minutes to complete a meal)
Subjects for whom written consent was received from the subject or a family member
Key exclusion criteria
Subjects with a life expectancy of less than one year
Subjects receiving tube feeding
Subjects who had confirmed (or suspected) pneumonia within the past month.
Subjects who are otherwise found to be ineligible by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Higashiguchi |
Organization
Fujita Health University
Division name
Surgery & Palliative medicine
Zip code
Address
1-98, Dengakuga-kubo, Kutsukake-cho, Toyoake city, Aichi prefecture
TEL
059-252-3058
t-gucci30219@herb.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Oshima |
Organization
Fujita Academy
Division name
Corporate headquarters, General Affairs Division
Zip code
Address
1-98, Dengakuga-kubo,,Kutsukake-cho, Toyoake city, Aichi prefecture
TEL
0562-93-9672
Homepage URL
honbu-sg@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 21 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014507
