UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049733 |
|---|---|
| Receipt number | R000056564 |
| Scientific Title | A cross-sectional study on sleep problems and unmet support needs of renal disease patient |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2023/06/13 15:31:23 |
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Basic information
Public title
A cross-sectional study on sleep problems and unmet support needs of renal disease patient
Acronym
A cross-sectional study on sleep problems and unmet support needs of renal disease patient
Scientific Title
A cross-sectional study on sleep problems and unmet support needs of renal disease patient
Scientific Title:Acronym
A cross-sectional study on sleep problems and unmet support needs of renal disease patient
Region
| Japan |
Condition
Condition
chronic kidney disease, end-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A cross-sectional study on sleep problems and unmet support needs of renal disease patient
Basic objectives2
Others
Basic objectives -Others
cross-sectional survey, qualitative analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cross-sectional survey, Athens insomnia scalea, Sleep hygiene practice scale, free description
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons over 20 years of age and more, have been diagnosed with chronic kidney disease at least three months of ongoing treatment, are registered with the survey company
Key exclusion criteria
Persons under 20 years of age, have been diagnosed with chronic kidney disease for less than three months of ongoing treatment, are registered with the survey company
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nakamura-Taira |
Organization
Chuo University
Division name
Department of Psychology, Faculty of Letters
Zip code
1860004
Address
742-1 Higashinakano Hachioji-shi, Tokyo 192-0393 Japan
TEL
0426743844
nanako@tamacc.chuo-u.ac.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Nakamura-Taira |
Organization
Chuo University
Division name
Department of Psychology, Faculty of Letters
Zip code
1860004
Address
742-1 Higashinakano Hachioji-shi, Tokyo 192-0393 Japan
TEL
0426743844
Homepage URL
nanako@tamacc.chuo-u.ac.jp
Sponsor or person
Institute
Chuo University, Faculty of Letters, Department of Psychology,
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
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
the ethics committee of Chuo University
Address
1-13-27 Kasuga Bunkyo-ku, Tokyo Japan
Tel
03-3817-1605
hitorinri-grp@g.chuo-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
| 2022 | Year | 12 | Month | 08 | 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
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 12 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056564
