UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024785 |
|---|---|
| Receipt number | 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 | 2020/04/04 08:51:14 |
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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
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
naoko-tkym@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical & Health Sciences, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028485
