UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of supporting social participation through a cosmetic program for senior citizen
Title of the study (Brief title)	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	Hitomi Ishibashi
Organization	Tokyo University of Technology
Division name	Dep. of Occu.Ther., School of Health Sciences
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	Hitomi Ishibashi
Organization	Tokyo University of Technology
Division name	Dep. of Occu.Ther., School of Health Sciences
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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