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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012407
Receipt No. R000014376
Scientific Title A project to prevent the worsening of diabetic nephropathy in Kure city: A study of the effectiveness of the program to prevent the aggravation of CKD
Date of disclosure of the study information 2013/11/26
Last modified on 2021/04/01

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Basic information
Public title A project to prevent the worsening of diabetic nephropathy in Kure city: A study of the effectiveness of the program to prevent the aggravation of CKD
Acronym Effectiveness of CKD disease management program
Scientific Title A project to prevent the worsening of diabetic nephropathy in Kure city: A study of the effectiveness of the program to prevent the aggravation of CKD
Scientific Title:Acronym Effectiveness of CKD disease management program
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to develop the CKD self-management program and to verify the effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The number of subjects who moved to ESKD, initiated RRT, newly onset of CVD (cerebrovascular disease, coronary artery disease, and heart failure), and the number of death.
Key secondary outcomes Physiological indicators: BP, Body Mass Index (BMI), urine protein, Scr, eGFR, BUN, UA, and non high-density lipoprotein cholesterol (non HDL-c), and other data.
Psychological indicator: the self-efficacy scale on health behavior in patients with chronic disease.
The process indicators: the proportion of days in a month that subjects performed the following self-management behaviors.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Long-term patient education by trained nurses
Interventions/Control_2 Usual education by trained nurses
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

Not applicable
Gender Male and Female
Key inclusion criteria Participants are the beneficiaries of Kure-city national health insurance, aged over 40 years who received a specific medical check-up of 2012 and 2013, met criteria as described in the below, and provided informed consent to participate.
Inclusion criteria were
(1) urine protein level is higher than 2+, or
(2) urine protein level is 1+ and an estimated glomerular filtration rate (eGFR) between 15 to 44 mL/min/1.73 m2 at the registration point, and
(3) no diagnosis of diabetic nephropathy at the registration point.
Key exclusion criteria Exclusion criteria were
(1) having introduced RRT,
(2) died,
(3) cognitively impaired or mental disorders, and
(4) when his/her primary physician judged that the enforcement of the program causes problems on the patients.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name MORIYAMA
Organization Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name Division of Nursing Science
Zip code 734-8553
Address Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima, 734-8553 Japan
TEL 082-257-5365
Email morimich@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Moriyama
Organization Hiroshima University, Graduate School of Biomedical and Health Sciences
Division name Division of Nursing Science
Zip code 734-8553
Address Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima, 734-8553 Japan
TEL 082-257-5365
Homepage URL
Email nkymssm1881@hotmail.co.jp

Sponsor
Institute Hiroshima University, Graduate School of Biomedical and Health Sciences
Institute
Department

Funding Source
Organization JSPS (Japan)(April 2013 to March 2014)
Kure-city local government (April 2014 to March 2015)
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University Hospital, Center for Integrated Medical Research
Address Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima, 734-8551 Japan
Tel 082-257-1725
Email protocol@cimr.hiroshima-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
2013 Year 11 Month 26 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 41
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Writing a manuscript
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
2013 Year 08 Month 01 Day
Date of IRB
2013 Year 09 Month 25 Day
Anticipated trial start date
2013 Year 09 Month 25 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 26 Day
Last modified on
2021 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014376

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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