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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026448
Receipt No. R000030385
Scientific Title Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen
Date of disclosure of the study information 2017/03/07
Last modified on 2017/03/07

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Basic information
Public title Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen
Acronym Effectiveness of the occupational therapy program using sspc.
Scientific Title Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen
Scientific Title:Acronym Effectiveness of the occupational therapy program using sspc.
Region
Japan

Condition
Condition Geriatrics
Psychiatry
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to understand HRQOL and daily life outcome for older adults who take a standard occupational therapy using crafts and those who take an occupational therapy using cosmetic which we have been developing.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes WHOQOL-BREF
SF-12
EQ-5D-5L
OSA ver.2.1
Frenchay Activities Index
Key secondary outcomes MMSE
Budget

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
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 Eight times a four month period.Program pertains to instruction/practice of daily life and cosmetic skills in a group.In seventh times, participants would do one occupation he/she wants to do(i.e, shopping, outdoor, studying).
Interventions/Control_2 Eight times a four month period.We perform the group program using crafts as a standard program of the occupational therapy.
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 Female
Key inclusion criteria Subjects entitled to long term care insurance community support program and/or preventive support project.
Key exclusion criteria Excluded are persons who receive care grade1 and over.
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitomi Ishibashi
Organization Tokyo University of Technology
Division name Dep. of Occu.Ther., School of Health Sciences
Zip code
Address 5-23-22 Nishi-kamata, Ota-city, Tokyo, Japan
TEL 81-3-6424-2145
Email hishibashiteu@stf.teu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Ishibashi
Organization Tokyo University of Technology
Division name Dep. of Occu.Ther., School of Health Sciences
Zip code
Address 5-23-22 Nishi-kamata, Ota-city, Tokyo, Japan
TEL 81-3-6424-2145
Homepage URL
Email hishibashiteu@stf.teu.ac.jp

Sponsor
Institute Tokyo University of Technology, School of Health Sciences, department of occupational therapy
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokyo Metropolitan University, Kao Corporation
Name of secondary funder(s) Japan society for the promotion of science, Grant-in-Aid for Young Scientists (B)

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 03 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 29 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 06 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 08 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 07 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=R000030385

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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