UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013119
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email honbu-sg@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.