UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031841 |
|---|---|
| Receipt number | 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 09:10:45 |
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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
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
sugita@ndmc.ac.jp
Sponsor or person
Institute
National Defense medical college.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036291
