UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023177
Receipt number 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 01:52:46

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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 or person

Institute

Yamaguchi University Graduate School of Medicine, Faculty of Health Sciences

Institute

Department

Personal name



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

Value
https://center6.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