UMIN-CTR Clinical Trial

Basic information
Public title	Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Acronym	Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Scientific Title	Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Scientific Title:Acronym	Assessment and measurement of pain in elderly dementia patients by computer vision systems.
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Psychiatry Anesthesiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the system for detecting the pain of elderly dementia patients by analyzing facial expressions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To detect the tendency of facial movements by monitoring facial expressions with pain.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subject over 65 year-old with dementia 2. Subject over 65 year-old without dementia
Key exclusion criteria	1.Subject who can not obtain consent from proxies Subjects with serious complications Subjects that the researcher judged inappropriate 2.Subject who can not get consent Subjects with serious complications Subjects that the researcher judged inappropriate
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kawano
Organization	Kochi Medical School
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-city, Kochi
TEL	088-880-2471
Email	takashika@kochi-u.ac.jp

Public contact
Name of contact person	1st name Marie Middle name Last name Shigematsu Locatelli
Organization	Kochi Medical School
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku-city, Kochi
TEL	088-880-2471
Homepage URL
Email	jm-marieslocatelli@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

Funding Source
Organization	none
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	Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku-city, Kochi
Tel	088-880-2180
Email	rinri21@kochi-u.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	2022 Year 07 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	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2018 Year 08 Month 05 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry	2021 Year 09 Month 30 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	none

Management information
Registered date	2019 Year 07 Month 17 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041480