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
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
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
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
