UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060294 |
|---|---|
| Receipt number | R000068972 |
| Scientific Title | Homecare AI Integrated System for Accelerated Intervention Project -Creating Highly Useful & Responsive Assessments with Deep Learning for Optimized Homecare Insights- |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 16:32:59 |
* 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
Homecare AI System for Assistance and Intervention Study
Acronym
HAISAI study
Scientific Title
Homecare AI Integrated System for Accelerated Intervention Project
-Creating Highly Useful & Responsive Assessments with Deep Learning for Optimized Homecare Insights-
Scientific Title:Acronym
HAISAI study - CHURA-DL-
Region
| Japan |
Condition
Condition
Patients have been receiving and planning to receive home medical care.
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Develop and implement an integrated AI homecare system that monitors the daily health status of homecare patients through various Digital Health Technology (DHT) domains and Patient-Reported Outcome (PRO) domains, creating a one-stop platform that enables communication among healthcare professionals, caregivers, and patients.
2.Analyze the collected data/information using deep learning techniques to conduct clinical research on prognosis prediction and health status signals, thereby demonstrating the usefulness of the AI integrated homecare system.
Basic objectives2
Others
Basic objectives -Others
To evaluate the usefulness of Homecare AI Integrated System into home medical care based on 1-year event-free survival proportion.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1-year event-free survival rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are already receiving homecare medical services or who will initiate homecare medical services after the start of the study, and who understand the study content and have provided written informed consent from the patient or their caregiver.
2.Patients who are already receiving homecare medical services or who will initiate homecare services after the start of the study, understand the study content, and have provided written informed consent from the patient or their caregiver, but who are unable to access the AI-integrated homecare system through electromagnetic methods.
3.Healthcare or caregiving staff at the participating medical institutions to use the AI-integrated homecare system for this study, who have obtained appropriate consent to answer the Perceived Stress Scale questionnaire.
Key exclusion criteria
1.Patients receiving homecare who do not fulfill the eligibility criteria
2.Healthcare or caregiving staff who do not fulfill the inclusion criteria
Target sample size
215
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Tamaki |
Organization
Nahanishi Clinic
Division name
Not applicable
Zip code
901-0154
Address
2-1-9 Akamine, Naha city, Okinawa, Japan
TEL
098-888-0087
nahanisikenta@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Munenori |
| Middle name | |
| Last name | Takata |
Organization
Tohoku University Hospital
Division name
Clinical Research Data Center
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7137
Homepage URL
munenori.takata.a3@tohoku.ac.jp
Sponsor or person
Institute
Nahanishi Clinic
Institute
Department
Personal name
Funding Source
Organization
TBD
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec-hosp@grp.tohoku.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
| 2026 | Year | 01 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The principal investigator's affiliated participating clinical sites, together with the Tohoku University Hospital Clinical Research Data Center, will lead the planning and establishment of the study's operational structure and will be responsible for project management, quality control, data aggregation/analysis, and dissemination of results. Case enrollment and collection of data/information will be carried out at the participating clinical sites. Data obtained from the preceding study (UMIN000049787) (secondary data use) and the data/information collected in this study will be analyzed using deep learning at the Tohoku University Hospital Clinical Research Data Center to generate prognostic predictions, and those results will be shared among the investigators.
Predictions produced by the deep learning models (e.g., signals or forecasts of symptom deterioration) are intended to be used as reference information for clinical staff, to be considered alongside information from patients and caregivers, the patient's clinical status, and clinicians' assessments; they are not meant to constitute direct interventions or to exert direct influence on patients. Final decisions regarding the need for treatment or medical interventions will rest with clinicians' professional judgment, taking these data into account.
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068972
