UMIN-CTR Clinical Trial

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