UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045890 |
|---|---|
| Receipt number | R000052365 |
| Scientific Title | Evaluation of digital care management effect verification |
| Date of disclosure of the study information | 2021/10/27 |
| Last modified on | 2023/03/06 15:53:45 |
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Basic information
Public title
Digital care management effect verification
Acronym
Digital care management effect verification
Scientific Title
Evaluation of digital care management effect verification
Scientific Title:Acronym
Digital care management effect verification
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to accurately grasp the living conditions of subject living at home, which could not be clarified since the implementation of the long-term care insurance system, by using digital devices. The effect of improving the quality of care management is to be confirmed by the care developed by the needs analysis based on the facts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical and mental condition and QOL of participants
Key secondary outcomes
QOL of family members
Changes in care itself
Changes in relationships between participants and their families, care managers in charge, and health, medical, and welfare professionals involved in support, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
*Period:12 weeks(In the case of extension, it will be implemented with the consent of the participants.)
*Research Time: 24 hours user's living information can be acquired by the following IoT
*Care managers support acquires IoT information and considers a care plan together with the subjects.
[List of IoT devices]
*Home network equipment: human sensor, open/close sensor, home unit,etc.
*Health and medical equipment:sphygmomanometer, activity meter,body composition meter(weight scale), etc.
*Environmental sensor: temperature/humidity measurement sensor
*Medication support equipment
*Weight sensor
*Message button
*Wi-Fi router
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older participants requiring long-term care who live in the target area and
*Living alone
*Judged that the care manager in charge needs to understand their daily activities
And subjects who have been selected based on the above selection criteria and the attributes of the target person, and who have consented to the following 5 items specified in the "Informed consent" for this project.
*Installation of IoT devices
*Electricity fee 235 yen / month (approximate)
*Provision of information
*Care plan examination
*Questionnaire
Key exclusion criteria
Since the sensor of the IoT device cannot identify participants and record only the behavior of the subjects, the following are excluded as research subjects.
*Person who lives with family
*Persons who keep pets such as dogs and cats that move around the room
Furthermore, the following diseases that may lead to personal identification are excluded from this project.
Diseases to be excluded: Amyotrophic lateral sclerosis, ossification of posterior longitudinal ligament, progressive supranuclear palsy, corticobasal degeneration, spinocerebellar degeneration, progeria, multiple system atrophy.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Ishiyama |
Organization
International University of Health and Welfare
Division name
Graduate School Development of Care and Network
Zip code
107-8402
Address
4-1-26 Akasaka Minato-ku Tokyo,107-8702
TEL
03-5574-3870
ishiyama.reiko@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Ishiyama |
Organization
International University of Health and Welfare
Division name
Graduate School Development of Care and Network
Zip code
107-8402
Address
4-1-26 Akasaka Minato-ku Tokyo
TEL
03-5574-3870
Homepage URL
ishiyama.reiko@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare IRB
Address
4-1-26 Akasaka Minato-ku Tokyo
Tel
03-5574-3900
rinri-tky@@iuhw.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
| 2021 | Year | 10 | Month | 27 | 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
13
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052365
