UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Atsuko Kawamura
Organization	Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name	Community / Gerontological Nursing
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	Atsuko Kawamura
Organization	Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences
Division name	Community / Gerontological Nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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