UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of remote medical support service using an information and communication technology (ICT) in patients with diabetic nephropathy: A pilot study with non-randomized control trial
Acronym	The study of effectiveness of ICT health service for patients with diabetic nephropathy
Scientific Title	The effectiveness of remote medical support service using an information and communication technology (ICT) in patients with diabetic nephropathy: A pilot study with non-randomized control trial
Scientific Title:Acronym	The study of effectiveness of ICT health service for patients with diabetic nephropathy
Region	Japan

Condition
Condition	Type 2 Diabetic nephropathy
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of remote medical support service among diabetic nephropathy patients using an ICT application. The first objective is pre and post comparison between intervention and control groups. The second one is to examine the suitability of ICT application's algorithm to the subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Physiological indicators: Blood pressure, pulse rate, BMI, fasting blood glucose, serum creatinine, nonHDL-cholesterol, triglycerides, eGFR, urine protein/urine albumin, HbA1c, change of the diabetic nephropathy stages 2. The number of patients who initiated Renal Replacement Therapy (RRT) 3. Behavioral indicators: -Amount of activity (the number of steps per month) -The percentage of lifestyle improvement -The percentage of program implementation following indicators (self-measurement times of blood pressure, pulse rate, fasting blood glucose and body weight) -The presence or absence of a regular consultation 4. Onset and progression of diabetic complication and disease: -Diabetic complications -Infectious diseases -Heart disease, cerebrovascular disease, peripheral artery disease, hypertension, dyslipidemia -Onset of foot lesion 5. Medical treatment of the following departments: (Ophthalmology, nephrology, internal medicine, neurology, dermatology, surgery, vascular surgery, dentistry, cardiology, urology, orthopedic, psychiatry) -Hospitalization (disease name), period, the number of frequencies 6. The function of ICT's application -Accessibility, satisfaction of application, the suitability of ICT's application
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Data monitoring and health education using an ICT application
Interventions/Control_2
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	20 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic nephropathy patients at Stages 1-3 according to the diabetic guideline 1. Beneficiaries of Hiroshima-city National Health Insurance and Union National Health Insurance living in Hiroshima prefecture, and the insured of Japan Health Insurance Association, Hiroshima chapter, and National Federation of Health Insurance Societies of Hiroshima. 2. A patient was judged by his/her general physician or physician in charge of diabetic treatment intended to participate in this study 3. An outpatient in diabetic treatment 4. Age =>20 and =<74 years old of both sexes 5. Not participate in another clinical study 6. The patient who can receive health education with PC or personal digital assistants (PDA)
Key exclusion criteria	1. A patient was judged as unable to measure blood pressure, pulse rate, blood glucose, and body weight by him/herself or family members 2. An inpatient 3. A patient at Renal Replacement Therapy (RRT) 4. A patient who has a plan for renal transplantation within 6 months 5. A patient at end stage 6. Type 1 diabetes and in case of secondary diabetes 7. Pregnant women 8. Dementia 9. Those who have behavioral problems and be considered as difficult to continue the program by a general physician or physician in charge of diabetic treatment or researcher
Target sample size	80

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

Public contact
Name of contact person	1st name Naoko Middle name Last name Takeyama
Organization	Graduate school of Biomedical & Health Sciences, Hiroshima University
Division name	Health Science Major
Zip code	734-8553
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL	082-257-5367
Homepage URL
Email	naoko-tkym@hiroshima-u.ac.jp

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

Funding Source
Organization	Hiroshima prefecture
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	Center for Integrated Medical Research
Address	1-2-3, Kasumi, Hiroshima city, Hiroshima, Japan
Tel	082-257-1752
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	2016 Year 11 Month 10 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	25
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	Completed
Date of protocol fixation	2016 Year 10 Month 19 Day
Date of IRB	2016 Year 10 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 28 Day
Last follow-up date	2018 Year 06 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	2016 Year 11 Month 10 Day
Last modified on	2020 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028485