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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023177
Receipt No. R000026721
Scientific Title A change of the consciousness to the health care for the eating function of the local older people whom the guidance of oral care and swallowing gymnastics brings
Date of disclosure of the study information 2016/07/14
Last modified on 2016/12/23

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Basic information
Public title A change of the consciousness to the health care for the eating function of the local older people whom the guidance of oral care and swallowing gymnastics brings
Acronym A change of the consciousness to the health care that the guidance of swallowing gymnastics brings
Scientific Title A change of the consciousness to the health care for the eating function of the local older people whom the guidance of oral care and swallowing gymnastics brings
Scientific Title:Acronym A change of the consciousness to the health care that the guidance of swallowing gymnastics brings
Region
Japan

Condition
Condition Healthy older people
Classification by specialty
Rehabilitation medicine Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For local olderly people, we perform questionary survey in about that we intervened in guidance of the explanation about oral care / the eating function and swallowing gymnastics, and a purpose of this study is to determine a change of the consciousness for the eating, consciousness to oral care, the consciousness about swallowing gymnastics and the consciousness to taking care of itself by oneself.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The consciousness of the self-care of the health
Key secondary outcomes The consciousness about a diet / the nutrient method / the oral function and the oral care / the eating function / the swallowing gymnastics /

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 We explain it about oral care, a change by the aging of the eating function, swallowing gymnastics.
We conduct swallowing gymnastics (three minutes) with study participants.
Interventions/Control_2
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) A person 65 years or older.
(2) Sex no object.
(3) A person (including the person who put on dentures) uneventful for an oral cavity function.
(4) The healthy older people who live in the area where the agreement was obtained in a document about participation with study.
Key exclusion criteria (1) The person who has difficulty with mutual understanding.
(2) The person with a history of jaw arthritis.
(3) The person who is in an incompatible state whom dentures are easy to come off.
(4) The person who has difficulty with informed consent.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Kawamura
Organization Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name Community / Gerontological Nursing
Zip code
Address 1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2810
Email atsuko@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Kawamura
Organization Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name Community / Gerontological Nursing
Zip code
Address 1-1-1-Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2810
Homepage URL
Email atsuko@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Institute
Department

Funding Source
Organization No fund
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 07 Month 14 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 Completed
Date of protocol fixation
2016 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
2017 Year 03 Month 15 Day
Date trial data considered complete
2017 Year 03 Month 20 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 14 Day
Last modified on
2016 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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