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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029595
Receipt No. 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 2017/10/16

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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
Email 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
Email mekita@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
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
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033786

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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