UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039457 |
|---|---|
| Receipt number | R000044215 |
| Scientific Title | Study on oral care program development focusing on dry mouth of hemodialysis patients |
| Date of disclosure of the study information | 2020/02/15 |
| Last modified on | 2024/08/23 09:05:46 |
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Basic information
Public title
Study on oral care program development focusing on dry mouth of hemodialysis patients
Acronym
Development of an oral care program focusing on dry mouth in hemodialysis patients
Scientific Title
Study on oral care program development focusing on dry mouth of hemodialysis patients
Scientific Title:Acronym
Development of an oral care program focusing on dry mouth in hemodialysis patients
Region
| Japan |
Condition
Condition
end stage renal disease (hemodialysis)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an oral care program that focuses on improving dry mouth in dialysis patients who have decreased salivary secretion due to the effects of dialysis. Furthermore, it is to clarify the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dry mouth
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Oral care for 3 months for subjects with dry mouth
Interventions/Control_2
Oral care for 3 months for subjects without dry mouth
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have obtained written and oral consent
Key exclusion criteria
There are no exclusion criteria
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Maeda |
Organization
Kumamoto University
Division name
Faculty of Life Sciences
Zip code
862-0976
Address
4-24-1 kuhonnji ,Chuo-ku,Kumamoto
TEL
096-373-5476
hmaeda@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Natsuka |
| Middle name | |
| Last name | Furusho |
Organization
Fukuoka Prefectural University
Division name
Faculty of Nursing
Zip code
825-2525
Address
4395 Ita ,Tagawa-City,Fukuoka
TEL
0947-42-2108
Homepage URL
furusho@fukuoka-pu.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
4-24-1 Honjyou ,Chuo-ku,Kumamoto
Tel
096-373-5009
ski-shien@jimu.kumamoto-u.ac.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 | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.34523/jscicn.202418002
Number of participants that the trial has enrolled
26
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to delay in study progress by covid-19
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
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044215
