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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041231
Receipt No. R000047083
Scientific Title Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Date of disclosure of the study information 2020/10/01
Last modified on 2020/07/28

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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

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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