UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029595 |
|---|---|
| Receipt number | R000033786 |
| Scientific Title | The evaluation for Improving cognitive function of elderly patients in intensive care unit with Unibo |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/04/21 11:06:18 |
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Basic information
Public title
The evaluation for Improving cognitive function of elderly patients in intensive care unit with Unibo
Acronym
The evaluation for Improving cognitive function of elderly patients in intensive care unit with Unibo
Scientific Title
The evaluation for Improving cognitive function of elderly patients in intensive care unit with Unibo
Scientific Title:Acronym
The evaluation for Improving cognitive function of elderly patients in intensive care unit with Unibo
Region
| Japan |
Condition
Condition
Elderly individuals aged 65 years or above who are admitted to the advanced medical emergency center
Classification by specialty
| Psychiatry | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Robot Assisted Therapy(RAT) will be carried out using Unirobot as a substitute for animals in animal therapy. Besides helping to reduce cognitive decline in elderly inpatients with RAT, the robot will also take on a portion of what is equivalent to the social activity support provided by care professionals after discharge. We also aim to reduce the relevant medical costs incurred through the reduction of long-term cognitive decline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the ADAS-Cog subtest (hereafter referred to as ADAS-Jcog) will be used to capture the chronological changes in cognitive function brought about by the effects of intervention. The frequency of test administration is once a week. The study adopts an A-B-A-B design, and because of the short hospitalization period in the acute care ward, A (nonintervention; no Unirobot) and B (intervention with Unirobot) will be evaluated every two weeks. The scores between A and B will then be reviewed by statistical analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Set up a Unirobot at the bedside of a patient The effect of the intervention will utilize the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version in order to understand the change of cognitive function over time. Inspection frequency is once a week. Study design is designated as A-B-A-B and evaluate A (No intervention: without Unirobot) and B (Intervention: with Unirobot) every two weeks due acute care ward patients stay hospital shorter and points of A and B are considered in statistical processing. Expected human research subject is 600 due approximately 300 elderly people is adopted to the advanced emergency medical service center annually.
Interventions/Control_2
Set up a Unirobot at the bedside of a patient The effect of the intervention will utilize the Alzheimer's Disease Assessment Scale-cognitive component-Japanese version in order to understand the change of cognitive function over time. Inspection frequency is once a week. Study design is designated as A-B-A-B and evaluate A (No intervention: without Unirobot) and B (Intervention: with Unirobot) every two weeks due acute care ward patients stay hospital shorter and points of A and B are considered in statistical processing. Expected human research subject is 600 due approximately 300 elderly people is adopted to the advanced emergency medical service center annually.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly individuals aged 65 years or above who are admitted to the advanced medical emergency center.
Key exclusion criteria
All individuals too bad situation of one's body to accept of this reserch.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Kitawaki |
Organization
Saitama Medical University
Division name
Support for medical personnel development center kawagoe branch
Zip code
Address
1981 Kamoda Kawagoe-shi Saitama-ken
TEL
0492283755
mekita@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Kitawaki |
Organization
Saitama Medical University
Division name
Support for medical personnel development center kawagoe branch
Zip code
Address
1981 Kamoda Kawagoe-shi Saitama-ken
TEL
0492283755
Homepage URL
mekita@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033786
