AI-supported Compassionate Healthcare Application for Self-care and Support

JRCT ID: jRCTs052230135

Registered date:24/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: HT, T2DM, Hyperlipemia, CKD, Metabolic syndrome, Liver dysfunction, Anemia, Hyperuricemia, IHD
• Date of first enrollment: 21/12/2023
• Target sample size: 2400
• Study type: Interventional
• Intervention(s): Participants receive disease risk prediction and health improvement plan simulated by AI from the results of health checkups using a smartphone application. Those who are subject to specific health guidance receive daily life support including diet and exercise guidance using the smartphone application by specialist such as public health nurses and dietitians.

Outcome(s)

• Primary Outcome: BMI

Secondary Outcome

>Physiological Indicators
blood pressure, pulse, blood test (HbA1c, blood glucose (fasting or casual), Cre, BUN, UA, LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides, GOT, GPT, gamma-GTP, TP, ALB, HGB), urine test (urine protein, urine sugar), occurrence of ischemic heart disease
>Behavioral indicators
degree of lifestyle improvement (stage of change) exercise habits, diet style, presence and degree of alcohol consumption and smoking, self-monitoring implementation rate, number of steps, percentage of physician or industrial physician visits, self-assessment of behavior changes, prescription and dosage, adverse event.
>Intervention model feasibility: convenience of the application and frequency of use of the application, satisfaction (program participants, health advisors), interviews with health advisors, time required for preparation and explanation of specific health guidance

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

>Individuals who own personal smartphone and can use it himself / herself.
>Individuals who provide consent for inclusion in the study.

Exclude criteria

>Individuals who have all of the following diseases (Hypertension, Type 2 Diabetes, Hyperlipemia).
>Individuals who have all of the following diseases (metabolic syndrome, chronic kidney disease, liver dysfunction, anemia, hyperuricemia, ischemic heart disease).
>Individuals who undergo treatment for malignant tumors, renal replacement therapy, type 1 diabetes, intractable diseases.
>Individuals who are certified for long-term care.
>Pregnant women.
>Undergoing inpatient treatment.
>Individuals who were recognized to be unsuitable for the study by research representative or researchers from a safety perspective

Related Information

• Primary Sponsor: Mineharu Yohei
• Source(s) of Monetary Support: Hankyu Hanshin Holdings, Inc.,Japan Agency for Medical Research and Development (AMED)