UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026448 |
|---|---|
| Receipt number | 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 19:13:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hishibashiteu@stf.teu.ac.jp
Sponsor or person
Institute
Tokyo University of Technology, School of Health Sciences, department of occupational therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030385
