UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035230 |
|---|---|
| Receipt number | R000039631 |
| Scientific Title | Effect of notification letter on behaviors and renal outcomes in chronic kidney disease |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2020/12/14 17:10:12 |
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Basic information
Public title
Effect of notification letter on behaviors and renal outcomes in chronic kidney disease
Acronym
Effect of notification letter in CKD patients
Scientific Title
Effect of notification letter on behaviors and renal outcomes in chronic kidney disease
Scientific Title:Acronym
Effect of notification letter in CKD patients
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effect of notification intervention on behavior and kidney function in patients with chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients who receive treatment within 6 months
Key secondary outcomes
eGFR change at health checkup after 2 years
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We send a conventional notification letter to the participants, informing risk for CKD progression and need for CKD treatment.
Interventions/Control_2
We send a behavior-economic-type notification letter to the participants, informing risk for CKD progression and need for CKD treatment using nudge of beahabior economic approach.
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Insured persons in the Health Insurance Association for Architecture and Engineering Companies
2.40-63 years old
3.Receiving health checkup and having results of urine testing and serum creatinine
CKD criteria of eGFR <60 mL/min or proteinuria >=1+
Key exclusion criteria
1. eGFR <15 mL/min at baseline
2. Having end stage renal disease at baseline
Target sample size
4250
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Fukuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Health Sciences
Zip code
6068507
Address
Shogoinkawahara 53, Sakyo, Kyoto
TEL
075-751-3925
fukuma.shingo.3m@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Fukuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Health Sciences
Zip code
6068507
Address
Shogoinkawahara 53, Sakyo, Kyoto
TEL
075-751-3925
Homepage URL
fukuma.shingo.3m@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
the Health Insurance Association for Architecture and Engineering Companies
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama City UNiversity, Keio University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2018 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
https://ci.nii.ac.jp/naid/120006716585/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
4500
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis completed for main outcomes
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039631
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
