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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039457
Receipt No. 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 2020/02/11

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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
Email 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
Email furusho@fukuoka-pu.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

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
Email 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 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 02 Month 20 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 11 Day
Last modified on
2020 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044215

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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