UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041855 |
|---|---|
| Receipt number | R000047782 |
| Scientific Title | The Evaluation of oral function in hemodialysis patients |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/21 18:22:44 |
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Basic information
Public title
The Evaluation of oral function in hemodialysis patients
Acronym
The evaluation of oral function and the functional training in hemodialysis patients
Scientific Title
The Evaluation of oral function in hemodialysis patients
Scientific Title:Acronym
The evaluation of oral function and the functional training in hemodialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis patients with impaired oral function
Classification by specialty
| Rehabilitation medicine | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of oral function, and Comparison of functional evaluation before and after oral function training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional evaluations will be performed and compared before the intervention and 3 and 6 months after the intervention.
a Oral hygiene b Dry mouth cNumber of remaining teeth d Decreased tongue lip motor function e Low tongue pressure f Swallowing dysfunction state
Key secondary outcomes
Age, gender, dialysis history, DM
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The intervention period is 6 months.
1,Training daily for cases with decreased oral function.
Pa-ta-ka-ra 5 times or (panda's treasure 5 times)
Tongue movement: (1) stick out or retract the tongue, (2) move it left and right, (3) move it up and down, (4) turn it a lot, and carry out daily training 1 to 3 times a day before meals.
2,10 cases, under 75 years old who can chew gum, chew gum for 15 minutes before starting HD.
Tongue movement and gum chewing training are separate cases.
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
| 60 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients
Key exclusion criteria
When consent from the patient or their representatives is not available for participation in this study.
Any other cases that doctors consider inappropriate for participation in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Takahashi |
Organization
Social medical corporation Kawashimakai
Kawashima Toseki Clini
Division name
Nursing department
Zip code
770-0011
Address
1-6 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL
088-634-0200
zunko.t@khg.or.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Takahashi |
Organization
Social medical corporation Kawashimakai Kawashima Toseki Clini
Division name
Nursing department
Zip code
770-0011
Address
1-6 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL
088-634-0200
Homepage URL
zunko.t@khg.or.jp
Sponsor or person
Institute
Social medical corporation Kawashimakai Kawashima Toseki Clinic
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation Kawashimakai Kawashima Toseki Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social medical corporation Kawashimakai Kawashima Toseki Clinic
Address
1-6 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
Tel
088-634-0200
zunko.t@khg.or.jp
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
| 2020 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047782
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
