UMIN-CTR Clinical Trial

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 (Main research) + (Attached research: A test to improve the health guidance AI prototype) + (Attached research: Expanding target diseases)
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 (Attached research: A test to improve the health guidance AI prototype)
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, COPD, Heart failure
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.
Basic objectives2	Others
Basic objectives -Others	Development of a system and the evaluation (Implement the developed health guidance AI prototype to patients, confirm the improvement effect of the behavioral changes of the patients, and obtain the evaluations of the improvements of the AI from the patients and nurses to improve the accuracy of the AI.) (Conduct and evaluate health guidance for patients with COPD and heart failure. Input the data to the AI built in the main research.)
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Feasibility evaluation of the system (Attached research: (1) After the nurse provided the health guidance according to the health guidance provided by the AI, did the patient change behavior as planned? (2) The degree of agreement between the risks, health guidance content, and action goals presented by AI and the nurses' thoughts) (Attached research: Change levels of behaviors)
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) (Attached research: Implementation of AI-based disease management program (1-2 months)) (Attached research (COPD & HF): Self-management education (3 months)
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. (Attached research) Outpatients of Hiroshima University Hospital aged 20 years and over with the following disease: Diabetes mellitus/diabetic nephropathy (Stage 1-4), CKD (stage G1 to G4), myocardium Infarction/angina, stroke / TIA (up to modify Rankin Scale 3) (Attached research) 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. COPD: GOLD stage 2-4, HF: AHA/ACC stage B & C
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	240

Research contact person
Name of lead principal investigator	1st name Michiko Middle name Last name Moriyama
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8553
Address	Hiroshima
TEL	082-257-5365
Email	morimich@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Michiko Middle name Last name Moriyama
Organization	Hiroshima University
Division name	Graduate School of Biomedical and Health Sciences
Zip code	734-8553
Address	Hiroshima
TEL	082-257-5365
Homepage URL	https://aipom.hiroshima-u.ac.jp/
Email	morimich@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 (Until March 2020). From April 2020, Hiroshima university & Hiroshima prefecture AI / IoT demonstration platform project
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	131
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Under journal submission
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	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	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The attached research (A test of health guidance AI prototype) was discontinued on June 15, 2020 (Registered cases:0). The attached research (Expanding target diseases: COPD & HF) was closed on Jan. 10, 2020, registered 24 cases, and 20 completed the study.

Management information
Registered date	2017 Year 09 Month 20 Day
Last modified on	2021 Year 04 Month 20 Day

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