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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029216
Receipt No. R000033394
Scientific Title Development of a health education system through risk prediction and targeting using artificial intelligence based on national health insurance claim data and health information
Date of disclosure of the study information 2017/09/22
Last modified on 2019/07/09

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Basic information
Public title Development of a health education system through risk prediction and targeting using artificial intelligence based on national health insurance claim data and health information
Acronym Development of a health education system using artificial intelligence
Scientific Title Development of a health education system through risk prediction and targeting using artificial intelligence based on national health insurance claim data and health information
Scientific Title:Acronym Development of a health education system using artificial intelligence
Region
Japan

Condition
Condition Hypertension, Diabetes, Diabetic nephropathy, Chronic kidney disease, Myocardial infarction, Angina pectoris, Stroke, Transient ischemic attack
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will analyze national health insurance claim data and health information by AI. Then we target high risk patients and provide them appropriate health education programs selected by AI. We evaluate the feasibility for further AI development (In 2017, the health education program will be provided without AI (regular face-to-face, and telenursing education. ).
Basic objectives2 Others
Basic objectives -Others Development of a system and the evaluation
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility evaluation of the system
Key secondary outcomes 1. Physiological indicators: blood test (HbA1c, BS, CRE, BUN, UA, LDL- C, HDL-C, TC, TG, GOT, GPT, r-GTP, PT-INR, TP, ALB, HGB, K, P), urine test(urine protein, urine albumin), blood pressure, weight, pulse rate, fasting blood glucose(if patient has diabates and measure it)
2. Treatment change: medication, introduction of renal replacement therapy
3. Behavioral indicators: lifestyle, content of meals, presence or absence of smoking/drinking, behavioral goals and achievement (meal, exercise, medication/injection, self-monitoring)
4. Disease, development of disease/complication
5. Regulary visit to a clinic, presence or absence of hospitalization, reason for hospitalization
6. Results of questionnares (self-efficacy, QOL)
7. Records of personal health education, diet records, reports for physicians
8. Records of face-to-face instruction, voice record of telephone instruction

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 Implementation of disease management programs (acquisition of self-management skills and lifestyle change, 3 month-period)
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

Not applicable
Gender Male and Female
Key inclusion criteria Beneficiaries of national Health insurances or medical care system for elderly in the later stage of life, who live in Hiroshima prefecture, are outpatients of medical facilities, and meet all criteria from 1 to 5 listed below.
1. A patient who falls into one of the two.
(1) A patient with any of the following diseases: Hypertension, Diabetes, Diabetic nephropathy, Chronic kidney disease, Myocardial infarction, Angina pectoris, Stroke, Transient ischemic attack (including a patient who quit the treatment)
(2) Based on health check-up data, a patient who has Hypertension (Grade 2 hypertension: systolic BP >= 160mmHg or diastolic BP >= 100mmHg), Hyperglycemia (HbA1c >= 7.0% or fasting blood suger >= 130mg/dl), Reduction of kidney function (eGFR < 60 or urine protein >= 2+)
2. A patients was judged by their general physician or physician in charge intended to participate in this study
3. Age >= 20 years old of both sexes
4. Not being participated in another clinical study
5. A patient who agrees with the written consent form.
Key exclusion criteria 1) A patient was judged by the nurses (who provide the program) as unable to implement the program
2) An inpatient
3) A patient at Renal Replacement Therapy (renal transplantation, treated with dialysis)
4) A patient who has a plan for renal transplantation within 6 months
5) A patient at end stage (be given a year to live)
6) Type 1 diabetes
7) In pregnacy
8) Dementia (HDS-R <= 20/30)
9) Those who have behavioral problems and be considered as difficult to continue the program by his/her primary physician, physician in charge of diabetic care or researcher
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuki
Middle name
Last name Kihara
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Hiroshima
TEL 082-257-1543
Email ykihara@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Kana
Middle name
Last name Kazawa
Organization Hiroshima University
Division name Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address Hiroshima
TEL 082-257-5382
Homepage URL https://aipom.hiroshima-u.ac.jp/
Email kkazawa@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University, The research project management committee for development of AI health education system
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Hiroshima University research ethics committee
Address Kasumi 1-2-3 Minami-ku, 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
2017 Year 09 Month 22 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 14 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2017 Year 09 Month 14 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033394

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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