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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044267
Receipt No. 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

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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
Email 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
Email t_kato@gifu-u.ac.jp

Sponsor
Institute Gifu University, Tokai National Higher Education and Research System
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050537

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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