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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035230
Receipt No. 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 2019/04/17

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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
Middle name
Last name Shingo Fukuma
Organization Kyoto University Graduate School of Medicine
Division name Human Health Sciences
Zip code
Address Shogoinkawahara 53, Sakyo, Kyoto
TEL 075-751-3925
Email fukuma.shingo.3m@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Fukuma
Organization Kyoto University Graduate School of Medicine
Division name Human Health Sciences
Zip code
Address Shogoinkawahara 53, Sakyo, Kyoto
TEL 075-751-3925
Homepage URL
Email fukuma.shingo.3m@kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine, Human Health Sciences
Institute
Department

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
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 12 Month 12 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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 12 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039631

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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