UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012407 |
|---|---|
| Receipt number | 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 09:31:33 |
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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
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
nkymssm1881@hotmail.co.jp
Sponsor or person
Institute
Hiroshima University, Graduate School of Biomedical and Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014376
| Research Plan | |
|---|---|
| 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 |
