UMIN-CTR Clinical Trial

Basic information
Public title	Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Acronym	Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Scientific Title	Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Scientific Title:Acronym	Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Basic data for nurses to perform cognitive rehabilitation for elderly people in a remote environment, verify changes in cerebral blood flow due to the involvement of nurses, and examine effective cognitive rehabilitation implementation methods
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Regarding the cerebral blood flow data, the Hb T change value with 0 at the start of measurement is compared before and after the median value and the interquartile range (IQR) before and after the involvement of the nurse.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Subject gazes at plain drawing paper for 90 seconds. We collect the values obtained from fNIRS. Subjects perform the same tasks as cognitive rehabilitation performed alone. At that time, the nurse interacts with the subject in a remote environment. We collect the values obtained from fNIRS.
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 old or older living in Takatsuki City, who do not interfere with daily life in terms of sight, hearing and language ability. It is intended for those who use health salons and day services implemented at joint research facilities. About 40 elderly people participate in health salons and day services conducted at the joint research facility. From the previous studies, it is estimated that the number of people who can carry out the exercise is about 10 people. Participants will be added each time there is a subject that can be conducted within the study period.
Key exclusion criteria	Those with a history of mental illness or cerebrovascular disease and higher brain dysfunction, those with an MMSE of 23 or less, and those with visual acuity or hearing that are difficult to live in daily life are excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Masakazu Middle name Last name Kubota
Organization	Osaka Medical College
Division name	Faculty of Nursing
Zip code	5690095
Address	7-6 Hacchonishi-machi, Takatsuki-City, Osaka
TEL	0726847223
Email	fon153@osaka-med.ac.jp

Public contact
Name of contact person	1st name Masakazu Middle name Last name Kubota
Organization	Osaka Medical College
Division name	Faculty of Nursing
Zip code	5690095
Address	7-6 Hacchonishi-machi, Takatsuki-City, Osaka
TEL	0726847223
Homepage URL
Email	fon153@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
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	Osaka Medical College
Address	7-6 Hacchonishi-machi, Takatsuki-City, Osaka
Tel	0726847223
Email	fon153@osaka-med.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	2020 Year 10 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	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2025 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	2020 Year 07 Month 28 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047083