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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022992
Receipt No. R000025967
Scientific Title Algorithm verification of facilities and visit type services for the prevention day care users
Date of disclosure of the study information 2016/07/07
Last modified on 2017/03/07

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Basic information
Public title Algorithm verification of facilities and visit type services for the prevention day care users
Acronym Algorithm verification of prevention services for day care users
Scientific Title Algorithm verification of facilities and visit type services for the prevention day care users
Scientific Title:Acronym Algorithm verification of prevention services for day care users
Region
Japan

Condition
Condition Geriatrics
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the prophylactic efficacy of home-visiting occupational therapy, provided additional to day service, that focuses on daily life activities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Assessment of Motor and Process Skills
SF-12
EQ-5D-5L
Barthel Index
Frenchay Activities Index
Budget
Key secondary outcomes Mini Mental State Examination
TMIG-IC

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Three times or more over a three month period. Intervention pertains to instruction/practice of daily life performance. Intervention conducted in the places of the research subject's choice (home, community).
Interventions/Control_2 no treatment
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 Subjects entitled to long-term care insurance community support home-visiting service C
Key exclusion criteria Excluded are persons receiving home visiting rehabilitation by occupational therapist and/or physiotherapist.
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yu Ishibashi
Organization Tokyo Metropolitan University
Division name Division of Occupational Therapy
Zip code
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 81-3-3819-1211
Email yu-ishi@tmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Ishibashi
Organization Tokyo Metropolitan University
Division name Division of Occupational Therapy
Zip code
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 81-3-3819-1211
Homepage URL
Email yu-ishi@tmu.ac.jp

Sponsor
Institute Tokyo Metropolitan University,Department of Human Health Sciences
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

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
2016 Year 07 Month 07 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
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 03 Day
Last modified on
2017 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025967

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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