UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044267 |
|---|---|
| Receipt number | R000050537 |
| Scientific Title | Verification of benefits by the prevention program for deterioration of diabetic nephropathy in Japan: Effects of medical consultation by public health nurse or registered dietitian using telephone on the rate of hospital/clinic visits for diabetes among patients never having hospital/clinical visits and patients discontinuing hospital/clinical visits |
| Date of disclosure of the study information | 2021/05/19 |
| Last modified on | 2021/05/19 17:33:02 |
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Basic information
Public title
Verification of benefits by the prevention program for deterioration of diabetic nephropathy in Japan: Effects of medical consultation by public health nurse or registered dietitian using telephone on the rate of hospital/clinic visits for diabetes among patients never having hospital/clinical visits and patients discontinuing hospital/clinical visits
Acronym
PPDN-J
Scientific Title
Verification of benefits by the prevention program for deterioration of diabetic nephropathy in Japan: Effects of medical consultation by public health nurse or registered dietitian using telephone on the rate of hospital/clinic visits for diabetes among patients never having hospital/clinical visits and patients discontinuing hospital/clinical visits
Scientific Title:Acronym
PPDN-J
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is important to encourage hospital/clinical visits for diabetes to patients never having hospital/clinical visits and those discontinuing hospital/clinical visits, who are at elevated risk of deterioration of diabetes nephropathy; and engage these patients to appropriate diabetes treatment. To this end, medical consultation by public health nurse or registered dietitian have been promoted through the nationwide prevention program for deterioration of diabetic nephropathy in Japan. The current study was designed to validate effects of medical consultation by public health nurse or registered dietitian using telephone on the rate of hospital/clinic visits for diabetes among patients never having hospital/clinical visits and patients discontinuing hospital/clinical visits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of hospital/clinic visits for diabetes
100X[the number of insured patients who visited hospital/clinic visits for diabetes (ICD-10 E10-E14) after medical consultation*] divided by [the number of insured patients who received medical consultation]
*, medical consultation (i.e., notification letter, telephone or home visit) conducted at last
Key secondary outcomes
the rate of hospital/clinic continuous visits for diabetes
100X[the number of insured patients who visited hospital/clinic visits for diabetes (ICD-10 E10-E14) twice or more after medical consultation*] divided by [the number of insured patients who received medical consultation]
*, medical consultation (i.e., notification letter, telephone or home visit) conducted at last
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Other |
Interventions/Control_1
Notification letter plus medical consultation by public health nurse or registered dietician using telephone
Interventions/Control_2
Notification letter
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Insured patients never having hospital/clinical visits and those discontinuing hospital/clinical visits who meet following inclusion criteria:
1) Never having hospital/clinical visits
- With diabetes nephropathy stage 1 or 2 (see below for definition)
- Without no diabetes treatment in interview at medical health checkup
- Without diabetes disease code in health insurance claims (FY2018 to FY2021)
- Without diabetes drug code in health insurance claims (FY2018 to FY2021)
2) Patients discontinuing hospital/clinical visits
2-1) Patients who meet following all criteria with medical health checkup in 2020:
- With diabetes nephropathy stage 1 or 2 (see below for definition)
- Without no diabetes treatment in interview at medical health checkup
- Meeting following all criteria:
# Without diabetes disease code in health insurance claims (January to March, 2022)
# Without diabetes drug code in health insurance claims (January to March, 2022)
# Meeting one of following criteria:
$ With diabetes disease code in health insurance claims (April 2018 to December 2021)
$ Patients with diabetes drug code in health insurance claims (April 2018 to December 2021)
2-2) Patients who meet following all criteria without medical health checkup in 2020:
# Without diabetes disease code in health insurance claims (January to March, 2022)
# Without diabetes drug code in health insurance claims (January to March, 2022)
# Meeting one of following criteria:
$ With diabetes disease code in health insurance claims (April 2018 to December 2021)
$ With diabetes drug code in health insurance claims (April 2018 to December 2021)
(Definition of Patients with diabetes nephropathy stage 1 or 2)
Patients who meet following all criteria:
#HbA1c 6.5% or above; or fasting plasma glucose 126 mg/dL or above (casual plasma glucose 200 mg/dL or above)
#urinary protein (-) or (+/-)
Key exclusion criteria
1) Insured patients never having hospital/clinical visits and those discontinuing hospital/clinical visits who are suspected to have diabetes nephropathy stage 3 or above
(Definition of Patients with diabetes nephropathy stage 1 or 2)
Patients who meet following all criteria:
# HbA1c 6.5% or above; or fasting plasma glucose 126 mg/dL or above (casual plasma glucose 200 mg/dL or above)
# Albuminuria (300 mg/gCre or above), proteinuria (0.5g/gCre or above) or eGFR 30 ml/min/1.73m2 or below
2) Insured patients who show their intention not to participate the current study
Target sample size
3600
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yabe |
Organization
Gifu University, Tokai National Higher Education and Research System
Division name
Department of Diabetes, Endocrinology and Metabolism, Graduate School of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6377
ydaisuke@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Kato |
Organization
Gifu University, Tokai National Higher Education and Research System
Division name
Department of Diabetes, Endocrinology and Metabolism, Graduate School of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6377
Homepage URL
t_kato@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University, Tokai National Higher Education and Research System
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University, Tokai National Higher Education and Research System
Address
1-1 Yanagido, Gifu
Tel
058-230-6377
ydaisuke@gifu-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
| 2021 | Year | 05 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050537
| 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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