UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055885 |
|---|---|
| Receipt number | R000063170 |
| Scientific Title | Point-of-Care AI to Support Home Care |
| Date of disclosure of the study information | 2024/10/20 |
| Last modified on | 2025/03/14 10:53:30 |
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Basic information
Public title
Point-of-Care AI to Support Home Care
Acronym
Point-of-Care AI to Support Home Care
Scientific Title
Point-of-Care AI to Support Home Care
Scientific Title:Acronym
Point-of-Care AI to Support Home Care
Region
| Japan |
Condition
Condition
Healthy individuals and those with cognitive impairment
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a system for detecting cognitive decline and caregiver fatigue in elderly individuals living at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of cognitive impairment and caregiver burden using the developed system
Key secondary outcomes
Factors related to cognitive decline and caregiver fatigue
Acceptance rate of the system
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People living at home
Key exclusion criteria
People who have difficulty using wearable devices or tablets at home
People who cannot understand the researcher's explanations
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Amemiya |
Organization
Chiba University
Division name
Graduate school of nursing
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2402
amemiya-a@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Amemiya |
Organization
Chiba University
Division name
Graduate school of nursint
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2781
Homepage URL
amemiya-a@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Chiba University Graduate School of Nursing, Ethics Committee
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
Tel
043-226-2462
kango-rinri@chiba-u.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
| 2024 | Year | 10 | Month | 20 | 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
| 2024 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is a observational study aimed at developing a system for detecting cognitive decline and caregiver fatigue among elderly individuals living at home. Participants over the age of 60 who reside at home were recruited at local community events. Those who found it difficult to use wearable devices or tablets at home or could not understand the researcher's explanation were excluded. Participants were asked to use a proprietary voice diary application for a duration ranging from one month to one year, and their cognitive functions and mental health were assessed before and after this period. The data collected included cognitive function tests such as MMSE and MoCA-J, depression assessments like the CES-D, facial expressions and voice recordings captured by the application, and activity and sleep data from wrist-worn wearable devices. The analysis is conducted from two perspectives. The first perspective seeks to identify distinctive variables associated with cognitive function by dividing the results of the cognitive tests into three groups: healthy, mild cognitive impairment, and cognitive decline, and comparing variables among these groups. The second perspective focuses on identifying distinctive variables related to caregiver fatigue by dividing the participants into groups of caregivers and non-caregivers and comparing the variables between these groups. Recruitment for participants will continue from April 2024 to March 2026.
Management information
Registered date
| 2024 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063170
