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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031841
Receipt No. R000036291
Scientific Title Research of mutual goal setting effect of a dry weight setup which utilized body composition analysis.
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/23

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Basic information
Public title Research of mutual goal setting effect of a dry weight setup which utilized body composition analysis.
Acronym Research of mutual goal setting effect of a dry weight setup which utilized body composition analysis.
Scientific Title Research of mutual goal setting effect of a dry weight setup which utilized body composition analysis.
Scientific Title:Acronym Research of mutual goal setting effect of a dry weight setup which utilized body composition analysis.
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of research is a process in which a hemodialysis introduction patient does a suitable weight setup, and verify that it is effective to utilize the data of body composition analysis and to have a common target with a health professional.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in bodyweight gain rate due to Nursing intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Explain weight management to patients.
Interventions/Control_2 Do not intervene only with ordinary medical treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient who is hospitalized for introduction of hemodialysis for National Defense Medical hospital with chronic renal failure
Key exclusion criteria Patient with consciousness disorder.
Patients with mental disorders.
The patient of dementia
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Sugita
Organization National Defense medical college
Division name Division of nursing
Zip code
Address 3-2Namiki Tokorozawa City ,Saitama 359-8513 ,Japan
TEL 04-2995-1211
Email sugita@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Sugita
Organization National Defense medical college
Division name Division of nursing
Zip code
Address 3-2Namiki Tokorozawa City ,Saitama 359-8513 ,Japan
TEL 04-2995-1211
Homepage URL
Email sugita@ndmc.ac.jp

Sponsor
Institute National Defense medical college.
Institute
Department

Funding Source
Organization Grants-Aid for Scientific Research
Organization
Division
Category of Funding Organization Non profit foundation
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
2018 Year 04 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 Completed
Date of protocol fixation
2018 Year 03 Month 08 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 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
2018 Year 03 Month 22 Day
Last modified on
2020 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036291

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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