UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024785
Receipt No. R000028485
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
Date of disclosure of the study information 2016/11/10
Last modified on 2017/10/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Michiko Moriyama
Organization Chronic care & Family Nursing, Graduate School of Biomedical & Health Sciences, Hiroshima University
Division name Department of Nursing
Zip code
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
Middle name
Last name Naoko Takeyama
Organization Graduate school of Biomedical & Health Sciences, Hiroshima University
Division name Health Science Major
Zip code
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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
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
2017 Year 10 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.